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fresenius kabi (singapore) pte ltd - adalimumab - injection, solution - adalimumab 40mg/0.8ml

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

remedyrepack inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are indicated in the emergency treatment of allergic reactions (type i) including anaphylaxis to stinging insects (e.g., order hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care. none risk summary there are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. in animal reproductive studies, epinephrine administered by the subcutaneous route to rabbits, mice, and hamsters during the period of organogenesis was teratogenic at doses 7 times and higher than the maximum recommended human intramuscular and subcutaneous dose on a mg/m 2 basis. epinephrine is the first-line medication of choice for the treatment of anaphylaxis during pregnancy in humans. epinephrine should be used for treatment of anaphylaxis during pregnancy in the same manner as it is used in non-pregnant patients. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk: during pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. the prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. management of anaphylaxis during pregnancy is similar to management in the general population. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients. in conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. data animal data: in an embryofetal development study with rabbits dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including gastroschisis and embryonic lethality) at doses approximately 40 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). in an embryofetal development study with mice dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including embryonic lethality) at doses approximately 8 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). these effects were not seen in mice at approximately 4 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). in an embryofetal development study with hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine was shown to be teratogenic at doses approximately 7 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day). risk summary there is no information on the presence of epinephrine in human milk, the effects on breastfed infants, or the effects on milk production. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and non-breastfeeding patients. epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg may be administered to pediatric patients at a dosage appropriate to body weight [ see dosage and administration ( 2.1) ] . clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. since the doses of epinephrine delivered from epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. however, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. therefore, epinephrine injection, 0.3 mg should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [ see warnings and precautions ( 5.5), overdosage ( 10) ]. epinephrine injection usp, 0.3 mg (auto-injector) epinephrine injection usp, 0.3 mg = one dose of 0.3 mg epinephrine usp, 0.3 mg/0.3 ml epinephrine injection usp, 0.15 mg (auto-injector) epinephrine injection usp, 0.15 mg = one dose of 0.15 mg epinephrine usp, 0.15 mg/0.3 ml for allergic emergencies (anaphylaxis) patient information read this patient information leaflet carefully before using the epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) and each time you get a refill. there may be new information. you, your parent, caregiver, or others who may be in a position to administer epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector), should know how to use it before you have an allergic emergency. this information does not take the place of talking with your healthcare provider about your medical condition or your treatment. what is the most important information i should know about epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? 1. epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are single-dose automatic injection devices (auto-injectors) that contain epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). anaphylaxis can be life threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. symptoms of anaphylaxis may include: trouble breathing wheezing hoarseness (changes in the way your voice sounds) hives (raised reddened rash that may itch) severe itching swelling of your face, lips, mouth, or tongue skin rash, redness, or swelling fast heartbeat weak pulse feeling very anxious confusion stomach pain losing control of urine or bowel movements (incontinence) diarrhea or stomach cramps dizziness, fainting, or “passing out” (unconsciousness) 2. always carry your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg with you because you may not know when anaphylaxis may happen. talk to your healthcare provider if you need additional units to keep at work, school, or other locations. tell your family members, caregivers, and others where you keep your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg and how to use it before you need it. you may be unable to speak in an allergic emergency. 3. when you have an allergic emergency (anaphylaxis) use epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg right away. get emergency medical help right away. you may need further medical attention. you may need to use a second epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg if symptoms continue or recur. only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode. what are epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are disposable, pre-filled auto-injectors used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. each device contains a single dose of epinephrine. epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are for immediate self (or caregiver) administration and do not take the place of emergency medical care. you should get emergency help right away after using epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg. epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are for people who have been prescribed this medicine by their healthcare provider. the epinephrine injection, 0.3 mg (auto-injector) is for patients who weigh 66 pounds or more (30 kilograms or more). the epinephrine injection, 0.15 mg (auto-injector) is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms). it is not known if epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are safe and effective in children who weigh less than 33 pounds (15 kilograms). what should i tell my healthcare provider before using the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg? before you use epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg, tell your healthcare provider about all your medical conditions, but especially if you: have heart problems or high blood pressure. have diabetes. have thyroid problems. have asthma. have a history of depression. have parkinson’s disease. are pregnant or plan to become pregnant. it is not known if epinephrine will harm your unborn baby. are breastfeeding or plan to breastfeed. it is not known if epinephrine passes into your breast milk. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. tell your healthcare provider about all of your known allergies. especially tell your healthcare provider if you take certain asthma medicines. epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg and other medicines may affect each other, causing side effects. epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg may affect the way other medicines work, and other medicines may affect how epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg work. know the medicines you take. keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. use your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicines you take. how should i use epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? each epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) contains only 1 dose of medicine (single-dose). epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors deliver a fixed dose of epinephrine. the auto-injectors cannot be reused. do not try to reuse epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg after the device has been activated. it is normal for most of the medicine to remain in the auto-injector after the dose has been injected. the dose has been injected if the orange tip is extended and the window is blocked. epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg should be injected into the middle of your outer thigh (upper leg). it can be injected through your clothing if needed. do not inject into a vein or into the buttocks, fingers, toes, hands or feet. read the instructions for use at the end of this patient information leaflet about the right way to use epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. your healthcare provider will show you how to safely use the epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector). use your single-dose epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg exactly as your healthcare provider tells you to use it. you may need to use a second epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg if symptoms continue or recur. only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode. caution: never put your thumb, fingers, or hand over the orange tip. never press or push the orange tip with your thumb, fingers, or hand. the needle comes out of the orange tip. accidental injection into finger, hands or feet may cause a loss of blood flow to these areas. if an accidental injection happens, go immediately to the nearest emergency room. tell the healthcare provider where on your body you received the accidental injection. your epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) may come packaged with an epinephrine injection trainer and separate epinephrine injection trainer instructions for use. the epinephrine injection trainer has a grey color. the grey epinephrine injection trainer contains no medicine and no needle. keep the epinephrine injection trainer and the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors away from young children. the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors and epinephrine injection trainer are not toys. for young children, use of the epinephrine injection trainer and the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors should be supervised by an adult. periodically practice with your epinephrine injection trainer before an allergic emergency happens to make sure you are able to safely use the real epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) in an emergency. always carry your real epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection 0.15 mg (auto-injector) with you in case of an allergic emergency. additional training resources are available at www.tevaepinephrine.com. do not drop the auto-injector. if the auto-injector is dropped, check for damage and leakage. throw away (dispose of) the auto-injector and replace if damage or leakage is noticed or suspected. what are the possible side effects of epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg may cause serious side effects. the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg should only be injected into the middle of your outer thigh (upper leg). do not inject the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg into your: veins buttocks fingers, toes, hands, or feet if you accidentally inject epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg into any other part of your body, go to the nearest emergency room right away. tell the healthcare provider where on your body you received the accidental injection. rarely, patients who have used epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg may develop infections at the injection site within a few days of an injection. some of these infections can be serious. call your healthcare provider right away if you have any of the following at an injection site: redness that does not go away swelling tenderness the area feels warm to the touch cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during an injection. if you inject a young child with epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg, hold their leg firmly in place before and during the injection to prevent injuries. ask your healthcare provider to show you how to: hold the young child firmly in place (restrain). with 1 hand, quickly twist the yellow cap off the epinephrine injection, 0.3 mg auto-injector or the green cap off the epinephrine injection, 0.15 mg auto-injector in the direction of the “twist arrow” to remove it. grasp the auto-injector in your fist with the orange tip (needle end) pointing downward. with your other hand, pull off the blue safety release. if you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. talk to your healthcare provider about all your medical conditions. common side effects of epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg include: fast, irregular or “pounding” heartbeat sweating headache weakness shakiness paleness feelings of over excitement, nervousness or anxiety dizziness nausea or vomiting breathing problems these side effects may go away with rest. tell your healthcare provider if you have any side effect that bothers you or that does not go away. these are not all the possible side effects of the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. for more information, ask your healthcare provider or pharmacist. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? store epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg at room temperature between 68° to 77°f (20° to 25°c). protect from light. do not expose to extreme cold or heat. for example, do not store in your vehicle’s glove box and do not store in the refrigerator or freezer. examine the contents in the clear window of your auto-injector periodically. the solution should be clear. if the solution is discolored (pinkish or darker than slightly yellow) or contains solid particles, replace the unit. always protect your epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) from damage and water. the blue safety release helps to prevent accidental injection. keep the blue safety release on until you need to use epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg has an expiration date. replace it before the expiration date. throw away (dispose of) expired, unwanted, or unused epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg in an fda-cleared sharps disposal container. do not throw away the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal visit the fda’s website (https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know) for more information about how to throw away (dispose of) unused, unwanted or expired medicines. keep epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg and all medicines out of the reach of children. general information about the safe and effective use of epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use the epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg for a condition for which it was not prescribed. do not give your epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg to other people. this patient information leaflet summarizes the most important information about epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg. if you would like more information, talk to your healthcare provider. you can ask your pharmacist or healthcare provider for information about epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg that is written for health professionals. for more information and video instructions on the use of epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg go to www.tevaepinephrine.com or call 1-888-838-2872. what are the ingredients in epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg? active ingredients: epinephrine inactive ingredients: sodium chloride, sodium metabisulfite, sodium tartrate (dihydrate), hydrochloric acid, and water important information the epinephrine injection, 0.3 mg (auto-injector) has a yellow colored label. the epinephrine injection, 0.15 mg (auto-injector) has a green colored label. the epinephrine injection trainer has a grey color and contains no medicine and no needle. your auto-injector is designed to work through clothing. the blue safety release on the epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) helps to prevent accidental injection of the device. do not remove the blue safety release until you are ready to use it. choking hazard: the blue safety release is a small part that may become a choking hazard for children. throw away the blue safety release immediately after using epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injector. only inject into the middle of the outer thigh (upper leg). never inject into any other part of the body. never put your thumb, fingers, or your hand over the orange tip. the needle comes out of the orange tip. if an accidental injection happens, get emergency medical help right away. instructions for use epinephrine injection usp, 0.3 mg (auto-injector) epinephrine injection usp, 0.3 mg = one dose of 0.3 mg epinephrine usp, 0.3 mg/0.3 ml epinephrine injection usp, 0.15 mg (auto-injector) epinephrine injection usp, 0.15 mg = one dose of 0.15 mg epinephrine usp, 0.15 mg/0.3 ml for allergic emergencies (anaphylaxis) read this instructions for use carefully before you use epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. before you need to use your single-dose epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg auto-injector, make sure your healthcare provider shows you the right way to use it. parents, caregivers, and others who may be in a position to administer epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) should also understand how to use it as well. if you have any questions, ask your healthcare provider. your epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) [ppi image] a dose of epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg requires 3 steps: prepare, administer and get emergency medical help step 1. prepare epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg for injection [ppi ifu image 1] quickly twist the yellow cap off the epinephrine injection, 0.3 mg auto-injector or the green cap off the epinephrine injection, 0.15 mg auto-injector in the direction of the “twist arrow” to remove it. [ppi ifu image 2] grasp the auto-injector in your fist with the orange tip (needle end) pointing downward. with your other hand, pull off the blue safety release. important: the blue safety release is a small part that may become a choking hazard for children. throw away the blue safety release immediately after using epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg. note: the needle comes out of the orange tip. to avoid an accidental injection, never put your thumb, fingers or hand over the orange tip. if an accidental injection happens, get emergency medical help right away. step 2. administer epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg if you are administering epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg to a young child, hold the leg firmly in place while administering an injection. [1] place the orange tip against the middle of the outer thigh (upper leg) at a right angle (perpendicular) to the thigh. swing and push the auto-injector firmly until it ‘clicks’. the click signals that the injection has started. [1] hold firmly in place for 3 seconds (count slowly 1,2,3). the injection is now complete. [1] remove the auto-injector from the thigh. the orange tip will extend to cover the needle. if the needle is still visible, do not attempt to reuse it. [1] massage the injection area for 10 seconds. step 3. get emergency medical help now. you may need further medical attention. you may need to use a second epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) if symptoms continue or recur. take your used auto-injector with you when you go to see a healthcare provider. tell the healthcare provider that you have received an injection of epinephrine. show the healthcare provider where you received the injection. give your used epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) to the healthcare provider for inspection and proper disposal. ask for a refill, if needed. note: keep the epinephrine injection trainer and the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors away from young children. the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors and epinephrine injection trainer are not toys. for young children, use of the epinephrine injection trainer and the real epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg auto-injectors should be supervised by an adult. a carrying tube is not provided as seen with other products. epinephrine injection, 0.3 mg and epinephrine injection, 0.15 mg are single-dose injectable devices that deliver a fixed dose of epinephrine. the auto-injector cannot be reused. do not attempt to reuse epinephrine injection after the device has been activated. it is normal for most of the medicine to remain in the auto-injector after the dose is injected. the correct dose has been administered if the orange needle tip is extended and the window is blocked. your epinephrine injection, 0.3 mg (auto-injector) and epinephrine injection, 0.15 mg (auto-injector) may come packaged with an epinephrine injection trainer and separate epinephrine injection trainer instructions for use. the epinephrine injection trainer has a grey color. the grey epinephrine injection trainer contains no medicine and no needle. practice with your epinephrine injection trainer, but always carry your real epinephrine injection, 0.3 mg auto-injector or epinephrine injection, 0.15 mg auto-injector in case of an allergic emergency. if you are administering epinephrine injection, 0.3 mg or epinephrine injection, 0.15 mg to a young child, ask your healthcare provider to show you how to (1) hold the young child firmly in place (restrain), (2) with 1 hand, quickly twist the yellow cap off the epinephrine injection, 0.3 mg (auto-injector) or the green cap off the epinephrine injection, 0.15 mg (auto-injector) in the direction of the “twist arrow” to remove it, (3) grasp the auto-injector in your fist with the orange tip (needle end) pointing downward and (4) with your other hand, pull off the blue safety release, and how to properly hold the leg in place while administering a dose. do not try to take the epinephrine injection, 0.3 mg (auto-injector) or epinephrine injection, 0.15 mg (auto-injector) apart. this patient information and instructions for use have been approved by the u.s. food and drug administration. keep this and all medications out of the reach of children. epinephrine injection usp, 0.3 mg (auto-injector) epinephrine injection usp, 0.3 mg = one dose of 0.3 mg epinephrine usp, 0.3 mg/0.3 ml epinephrine injection usp, 0.15 mg (auto-injector) epinephrine injection usp, 0.15 mg = one dose of 0.15 mg epinephrine usp, 0.15 mg/0.3 ml tevaepinephrine.com register your epinephrine injection 0.3 mg (auto-injector) or epinephrine injection 0.15 mg (auto-injector) at www.tevaepinephrine.com and find out more about: free epinephrine injection auto-injector refill reminder program. it is important to keep your auto-injector up-to-date. register up to 6 epinephrine injection 0.3 mg (auto-injectors) or epinephrine injection 0.15 mg (auto-injectors) and receive automatic refill reminder alerts. receive periodic information related to allergies and allergens. instructional video for more information about epinephrine injection 0.3 mg (auto-injector) or epinephrine injection 0.15 mg (auto-injector) and proper use of the products, call teva at 1-888-838-2872 or visit www.tevaepinephrine.com. epinephrine injection trainer instructions for use in an emergency: do not use the grey trainer. use your real yellow epinephrine injection 0.3 mg auto-injector or real green epinephrine injection 0.15 mg auto-injector. important information the trainer label has a grey color. the trainer contains no medicine and no needle. keep the grey trainer away from young children. the trainer is not a toy. young children should only practice with the trainer under adult supervision. periodically practice with the grey trainer before an allergic emergency (anaphylaxis) happens to make sure you are able to safely use the real yellow epinephrine injection 0.3 mg auto-injector or real green epinephrine injection 0.15 mg auto-injector in case of an emergency. always carry your real yellow epinephrine injection 0.3 mg auto-injector or real green epinephrine injection 0.15 mg auto-injector in case of an allergic emergency. small parts like the blue safety release may become a choking hazard for children. put the blue safety release back on the trainer and reset it immediately after practicing. the epinephrine injection trainer familiarize yourself with this grey trainer. practice until you are comfortable using it. your grey trainer: [trainer-ifu image] • never put your thumb, other fingers, or hand over the orange tip (below grey safety cap). • the orange tip is where the needle comes out of your epinephrine injection 0.3 mg auto-injector or epinephrine injection 0.15 mg auto-injector. practice instructions [1] 1 prepare the trainer for simulated injection grasp the grey trainer in your fist with the orange tip pointing downward and twist off grey cap in the direction of “twist arrow”. with your other hand, pull off blue safety release. removing the blue safety release unlocks the trainer. 2 administer the trainer simulation if practicing with a young child, hold the leg firmly in place while using the epinephrine injection trainer. ask your healthcare provider to show you how to: 1. hold the young child firmly in place (restrain). 2. with 1 hand, quickly twist the grey cap off the epinephrine injection trainer in the direction of the “twist arrow” to remove it. 3. grasp the auto-injector in your fist with the orange tip (needle end) pointing downward. 4. with your other hand, pull off the blue safety release, and how to properly hold the leg to practice so that you will be prepared before an allergic emergency happens. [1] [1] place the orange tip against the middle of the outer thigh (upper leg) at a right angle (perpendicular) to the thigh. swing and push the trainer firmly until it ‘clicks’. the click signals that the injection has started. hold firmly in place for 3 seconds (count slowly 1,2,3). remove the trainer from the thigh and massage the injection area for 10 seconds. the orange tip automatically extends out after use. note: in an actual emergency, you would need to seek emergency medical help right away. the actual auto-injector is made to work through clothing. do not inject into any other part of the body. [1] 3 to reset the trainer put the blue safety release back on the trainer. replace grey cap. note: with the real yellow epinephrine injection 0.3 mg auto-injector or real green epinephrine injection 0.15 mg auto-injector, the orange tip covers the needle after self-injection to help protect you from accidentally sticking yourself or others. practice session information in case of an allergic emergency, use the real yellow epinephrine injection 0.3 mg auto-injector or real green epinephrine injection 0.15 mg auto-injector and not the grey trainer. follow instructions above. repeat as often as needed until you are able to self-inject quickly and correctly. reread: the trainer instructions for use the “patient information” that comes with your epinephrine injection 0.3 mg auto-injector or epinephrine injection 0.15 mg auto-injector train others who could help you in an emergency: • your parents, caregivers, and others who may be in a position to administer epinephrine injection 0.3 mg or epinephrine injection 0.15 mg should know how to help you during an allergic emergency (anaphylaxis). before an emergency occurs, have them: practice activating the trainer read these trainer instructions and the “patient information” for more information about the epinephrine injection 0.3 mg auto-injector and epinephrine injection 0.15 mg auto-injector and the proper use of the products, go to www.tevaepinephrine.com. caution: important differences between the trainer and your real yellow epinephrine injection 0.3 mg (auto-injector) or real green epinephrine injection 0.15 mg (auto-injector) [1] [0.3 mg injector] [0.15 mg injector] trainer (grey) epinephrine injection 0.3 mg (yellow) epinephrine injection 0.15 mg (green) contains medicine? no yes yes has needle? no yes yes comes in carrier tube? no no no color of label grey yellow green has expiration date? no yes yes can be reused? yes no (use only one time) no (use only one time) okay to remove and replace cap and/or safety release? yes no (remove just one time before use) no (remove just one time before use) pressure needed to hold against thigh? moderate strong strong this trainer instructions for use has been approved by the u.s. food and drug administration. keep this and all medications out of the reach of children. repackaged and distributed by: remedy repack, inc. 625 kolter dr. suite #4 indiana, pa 1-724-465-

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

scpharmaceuticals inc. - furosemide (unii: 7lxu5n7zo5) (furosemide - unii:7lxu5n7zo5) - furoscix is indicated for the treatment of congestion due to fluid overload in adult patients with new york heart association (nyha) class ii and class iii chronic heart failure. furoscix is not indicated for use in emergency situations or in patients with acute pulmonary edema. the on-body infusor will deliver only an 80-mg dose of furoscix. - furoscix is contraindicated in patients with anuria, - furoscix is contraindicated in patients with a history of hypersensitivity to furosemide or medical adhesives - furoscix is contraindicated in patients with hepatic cirrhosis or ascites. risk summary available data from published observational studies, case reports, and post marketing reports, from decades of use, have not demonstrated a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with furosemide use during pregnancy. untreated congestive heart failure and cirrhosis of the liver can lead to adverse outcomes for the mother and the fetus (see clinical considerations). in animal reproduction studies, furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits when administered orally during organogenesis at 4 times a human i.v. dose of 80 mg based on body surface area (bsa) and oral bioavailability corrections, presumably secondary to volume depletion (see data). the estimated background risk for major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with congestive heart failure are at increased risk for pre-term birth. stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth. closely monitor pregnant patients for destabilization of their heart failure. pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, pre-term delivery, fetal growth restriction and maternal death. outcomes are worse with coexisting esophageal varices. carefully monitor pregnant women with cirrhosis of the liver. data animal data the effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats, and rabbits. furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (approximately 4 times the human i.v. dose of 80 mg based on bsa and oral bioavailability corrections). in another study, a dose of 50 mg/kg (approximately 7 times a human i.v. dose of 80 mg based on bsa and oral bioavailability corrections) also caused maternal deaths and abortions when administered to rabbits between days 12 and 17 of gestation. in a third study, none of the pregnant rabbits survived an oral dose of 100 mg/kg. data from the above studies indicate fetal lethality that can precede maternal deaths. the results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses of treated dams as compared with the incidence of fetuses from the control group. risk summary the presence of furosemide has been reported in human breast milk. there are no data on the effects on the breastfed infant or the effects on milk production. doses of furosemide associated with clinically significant diuresis may impair milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for furosemide and any potential adverse effects on the breastfed infant from furosemide or from the underlying maternal condition. safety and efficacy for pediatric use have not been established [see indications and usage ( 1)]. controlled clinical studies did not include sufficient numbers of subjects to determine whether subjects aged 65 and over respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for the elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. furoscix is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see clinical pharmacology ( 12.3)]. instructions for use model/ref # fur-80w5 lbl-0063 r12 instructions for use on-body infusor for furoscix® [fue roe’ six] (furosemide injection) for subcutaneous use single-use on-body infusor and 80 mg/10 ml (8 mg/ml) prefilled cartridge this instructions for use contains information about how to prepare and use furoscix on-body infusor. before starting - read this instructions for use before using the furoscix on-body infusor for the first time. - you or a caregiver should receive training before using the furoscix on-body infusor. - always wash your hands before starting. - the furoscix on-body infusor will deliver a fixed dose of 80 mg of furosemide over about 5 hours. - the furoscix on-body infusor delivers the medicine just under the skin (subcutaneously). - when the furoscix on-body infusor is started, a small needle sticks into the skin to deliver the medicine. the on-body infusor signals when all the medicine has been delivered. when the on-body infusor is removed from the skin, a needle cover will extend over the needle to protect from an accidental needle stick. parts of the furoscix on-body infusor and prefilled cartridge important information - the on-body infusor and prefilled cartridge are not made with natural rubber latex. - the infusion will last about 5 hours. during this time, you should limit your activity so that your bending movements are limited. wearing the infusor while riding in a car or flying in an airplane is not recommended. - you should notice an increase in urine production in about an hour after the infusion is started and may need to make frequent bathroom visits. be sure you have access to a bathroom for up to 8 hours after starting the infusion. if you do not notice the need to go to the bathroom, call your healthcare provider. - the on-body infusor can only be used with the prefilled furoscix cartridge supplied in the kit. - do not use any other cartridges or medicines inside the on-body infusor. - do not apply lotions, oils, or ointments to the adhesion area of the abdomen prior to applying the on-body infusor to the abdomen. - do not use the on-body infusor if the packaging appears to be opened, or if the on-body infusor has been dropped or appears to be broken or damaged. - do not use the on-body infusor within 12 inches of mobile phones, tablets, computers or wireless accessories (for example: tv remote control, bluetooth computer keyboard or mouse). - do not use the on-body infusor or prefilled cartridge after the expiration date on the carton. - do not use the prefilled cartridge if the liquid is discolored or cloudy. the liquid in the prefilled cartridge should be clear to slightly yellow in color. - do not use the on-body infusor in or around an mri machine. - do not take the on-body infusor off your skin while it is infusing, unless there is an emergency or a device error. removing the on-body infusor before the infusion is done will result in a partial dose. the on-body infusor will stop infusing and it cannot be restarted. do not apply a new on-body infusor unless instructed to do so by your healthcare provider. - do not reuse the on-body infusor. the on-body infusor is for single use only. - do not let the on-body infusor get wet from water or any other liquids. do not shower, bathe, swim or do activities that may make you sweat while wearing the on-body infusor. it contains parts that should not get wet. call your healthcare provider or scpharmaceuticals at 1-855-scpharma (1-855-727-4276) if you have any questions. storage information - the furoscix on-body infusor and prefilled cartridge should be stored at controlled room temperature between 68°f to 77°f (20°c to 25°c) (see figure b). do not refrigerate or freeze. - keep the furoscix prefilled cartridge in the original carton to protect from light or physical damage until you are ready to use. - keep the furoscix on-body infusor and prefilled cartridge out of the reach of children. prepare for the infusion step 1 wash hands, check expiration date and remove supplies from carton ​ 1.1 wash your hands before using the on-body infusor (figure c). 1.2 check the expiration date on the furoscix on-body infusor carton (see figure d). do not use if the expiration date has passed. 1.3 open the carton and peel away the white paper cover. remove the plastic cover from the clear tray. remove supplies from the carton and packaging (see figure e). do not use the on-body infusor or prefilled cartridge if packaging appears to have been previously opened or damaged. 1.4 gather all materials needed for your injection, on a clean, well-lit work surface (figure f): - on-body infusor and prefilled cartridge (included) - instructions for use (included) - alcohol wipes (included) - clippers (if needed) (not included) - sharps disposal container (not included) step 2 check on-body infusor and prefilled cartridge 2.1 check the on-body infusor and prefilled cartridge for any damage (see figure g). do not use the on-body infusor or prefilled cartridge if either item appears to be damaged. do not touch the blue start button until the on-body infusor is on the skin and you are ready to begin the infusion. do not touch or fully open the cartridge holder until you are ready to load the cartridge. 2.2 check the liquid medicine in the prefilled cartridge (see figure h). the liquid in the prefilled cartridge should be clear to slightly yellow. do not use the prefilled cartridge if the liquid is discolored or cloudy. call scpharmaceuticals at: 1-855-scpharma (1-855-727-4276) or call your healthcare provider. step 3 load prefilled cartridge into the on-body infusor 3.1 clean the tip (small end) of the prefilled cartridge with an alcohol wipe (see figure i). do not continue with the process of opening the cartridge holder all the way or loading the prefilled cartridge until you are ready to begin the infusion. 3.2 open the cartridge holder all the way to turn on the on-body infusor. the on-body infusor “beeps” and the indicator light will begin blinking blue (see figure j). note: complete steps 3.3 through 6.1 within 30 minutes of fully opening the cartridge holder or the infusor will alarm and cannot restart. 3.3 insert the prefilled cartridge into the cartridge holder with the tip pointed down (see figure k). note: the prefilled cartridge should slide into the cartridge holder easily. if it does not slide in easily, check the prefilled cartridge to make sure the tip is pointed down and try again. do not press the blue start button until on-body infusor is applied to skin and you are ready to begin the infusion. 3.4 close the cartridge holder all the way until it is even with the rest of the on-body infusor (see figure l). you may hear a “click” sound when it is closed. note: if the indicator light blinks red and the on-body infusor "beeps", the on-body infusor has experienced an internal error. do not use the on-body infusor (see on-body infusor alarm section). apply the on-body infusor step 4 select and prepare application site 4.1 select one site on the stomach on either side of the belly button (navel). the site should be a flat area below the rib cage and above the belt line (see figure m). do not select a site where the skin is irritated or broken. do not apply lotions, oils or ointments to the adhesion area of the abdomen. do not select a site where belts, waistbands or other types of clothing may rub against, disturb, or dislodge the on-body infusor. note : rotate application site (side of the stomach) each time if told by your healthcare provider to repeat dose. 4.2 the site should be hairless or nearly hairless. if needed, remove excess hair by clipping or shaving the hair before applying the on-body infusor (see figure n). 4.3 wipe the skin where the on-body infusor will be applied with an alcohol wipe and allow area to dry (see figure o). step 5 apply the on-body infusor 5.1 pick up the on-body infusor. peel away the adhesive liner by grasping the white tab and pulling it away from the blue tab/adhesive backing (see figure p). do not touch the sticky (adhesive) part of the on-body infusor with your fingers or let it touch any objects or surfaces before the infusor is placed on the skin. 5.2 apply the on-body infusor to the chosen skin site while standing or sitting up straight. position the on-body infusor so that the cartridge window and the indicator light can be seen during the infusion (see figure q). do not bend over when applying the on-body infusor. 5.3 press the on-body infusor firmly onto the skin and hold it for several seconds (see figure r). then rub your finger over the edges of the adhesive to get it to stick well. do not touch the blue start button until you are ready to start the infusion (see step 6). do not remove and reapply on-body infusor. the on-body infusor adhesive might not work as well. start the infusion step 6 start the infusion 6.1 firmly press and release the blue start button to begin the infusion (see figure s). the on-body infusor will stick a very small needle just under the skin and begin delivering the medicine. the indicator light will start blinking green and the on-body infusor "beeps", signifying that the infusion has begun. note: at the start of the infusion, you may also hear the on-body infusor motor running for several seconds. step 7 allow medicine to deliver for 5 hours 7.1 relax during the delivery period. the on-body infusor should remain on the skin until the delivery is complete. do not exercise or take part in activities that might result in the on-body infusor falling off. take care not to bump the on-body infusor while wearing it. it takes about 5 hours for the on-body infusor to deliver all of the medicine. during the infusion, the indicator light will continue to blink green periodically, signifying that the infusion is running (see figure t). note: if the on-body infusor falls off or if the indicator light begins blinking red, call your healthcare provider right away (see on-body infusor alarm section). do not reapply or reuse the on-body infusor. do not apply a new on-body infusor unless instructed to do so by your healthcare provider. if you have to stop the infusion due to an emergency, do the following: - remove the on-body infusor from the skin (see step 8). it will immediately stop infusing and the on-body infusor will deactivate. do not reuse the on-body infusor. after the on-body infusor is removed, it can no longer be used. - call your healthcare provider for further instructions. remove and dispose of the on-body infusor step 8 when infusion is complete, remove the on-body infusor from the skin 8.1 the infusion is complete and the on-body infusor is ready to be removed when (see figure u): - the indicator light turns solid green. - the on-body infusor "beeps". - the white plunger rod fills the cartridge window all the way. note: if indicator light begins blinking red instead of green and the on-body infusor “beeps”, call your healthcare provider (see on-body infusor alarm section). 8.2 peel the on-body infusor off the skin by holding the skin down and pulling on the blue tab (see figure v). when the on-body infusor is removed, the indicator light will turn off, the needle cover will extend over the needle to protect against accidental needle sticks, and the on-body infusor will turn off. note: you might have some discomfort after you remove the adhesive. this discomfort should quickly go away. however, some redness of the skin may remain. 8.3 check the infusion site. if there is any bleeding use a cotton ball or apply a small adhesive bandage. step 9 throw away (dispose) of used on-body infusor 9.1 dispose of the used furoscix on-body infusor and prefilled cartridge together into an fda-cleared sharps container (see figure w). do not attempt to remove the cartridge from the on-body infusor; it cannot be removed. do not throw away the used on-body infusor into household trash. if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle the on-body infusor or sharps disposal container or throw them into household trash. important: always keep the sharps disposal container out of the reach of children. for more information refer to: http://www.safeneedledisposal.org infusor alarm what happened? the indicator light blinks red and the on-body infusor "beeps" (see figure x). what does it mean? there has been an internal error or the on-body infusor came off the skin during the infusion. what to do? stop using the on-body infusor. if the on-body infusor is on the skin, carefully remove it. call your healthcare provider for further instructions. do not reapply or reuse the on-body infusor. it can no longer be used. do not apply a new on-body infusor unless instructed to do so by your healthcare provider. symbols legend scpharmaceuticals, inc. 25 mall road, suite 203, burlington, ma 01803 1-855-scpharma (1-855-727-4276) this instructions for use has been approved by the u.s. food and drug administration. issued: 10/2023

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

amgen inc - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - amjevita is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. amjevita can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). amjevita is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. amjevita can be used alone or in combination with methotrexate. amjevita is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. amjevita can be used alone or in combination with non-biologic dmards. amjevita is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. amjevita is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. amjevita is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf-blockers [see clinical studies (14.7)] . amjevita is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. amjevita should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see boxed warning and warnings and precautions (5)] . amjevita is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. amjevita is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn's disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data). adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations). in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester [see data ]. risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n = 10) and infant serum (n = 8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 mcg/ml in cord blood, 4.28-17.7 mcg/ml in infant serum, and 0-16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for amjevita and any potential adverse effects on the breastfed child from amjevita or from the underlying maternal condition. the safety and effectiveness of amjevita have been established for: - reducing signs and symptoms of moderately to severely active polyarticular jia in pediatric patients 2 years of age and older. - the treatment of moderately to severely active crohn's disease in pediatric patients 6 years of age and older. pediatric assessments for amjevita demonstrate that amjevita is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, amjevita is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to < 4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn's disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn's disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of amjevita in patients 65 years of age and older. in patients treated with amjevita, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . instructions for use welcome! the amjevita™ sureclick® autoinjector is a single-dose prefilled autoinjector. consult your doctor if you have any questions about your dose. your doctor has prescribed amjevita sureclick autoinjector for your injections. if your doctor decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your doctor or nurse. please read all of the instructions before using amjevita sureclick autoinjector. call your doctor if you or your caregiver have any questions about the right way to inject amjevita. instructions for use amjevita™(am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use single-dose prefilled sureclick® autoinjector guide to parts important: needle is inside important before you use an amjevita sureclick autoinjector, read this important information: storing your amjevita sureclick autoinjectors - keep the amjevita sureclick autoinjector and all medicines out of the reach of children. - keep the amjevita sureclick autoinjector in the original carton to protect from light or physical damage. - the amjevita sureclick autoinjector should be kept in the refrigerator at 36°f to 46°f (2°c to 8°c). - if needed, you may store the amjevita sureclick autoinjector at room temperature up to 77°f (25°c) for up to 14 days. throw away amjevita if it has been kept at room temperature and not been used within 14 days. - do not store the amjevita sureclick autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. - do not freeze. using your amjevita sureclick autoinjector - it is important that you do not try to give the injection unless you or your caregiver has received training from your doctor or nurse. - do not use the amjevita sureclick autoinjector after the expiration date on the label. - do not shake the amjevita sureclick autoinjector. - do not remove the yellow cap from the amjevita sureclick autoinjector until you are ready to inject. - do not use the amjevita sureclick autoinjector if it has been frozen. - do not use the amjevita sureclick autoinjector if it has been dropped on a hard surface. part of the amjevita sureclick autoinjector may be broken even if you cannot see the break. use a new amjevita sureclick autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the amjevita sureclick autoinjector is not made with natural rubber latex. for more information or help or call 1-800-77-amgen (1-800-772-6436). step 1: prepare a remove 1 amjevita sureclick autoinjector from the package. carefully lift the autoinjector straight up out of the box. put the original package with any unused autoinjectors back in the refrigerator. for a more comfortable injection, leave the autoinjector at room temperature for 15 to 30 minutes before injecting. - do not put the autoinjector back in the refrigerator once it has reached room temperature. - do not try to warm the autoinjector by using a heat source such as hot water or microwave. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector yet. b inspect the amjevita sureclick autoinjector. make sure the medicine in the window is clear and colorless to slightly yellow. - do not use the autoinjector if: the medicine is cloudy or discolored, or contains flakes or particles. any part appears cracked or broken. the autoinjector has been dropped. the yellow cap is missing or not securely attached. the expiration date printed on the label has passed. - the medicine is cloudy or discolored, or contains flakes or particles. - any part appears cracked or broken. - the autoinjector has been dropped. - the yellow cap is missing or not securely attached. - the expiration date printed on the label has passed. in all cases, use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). c gather all materials needed for your injection. wash your hands thoroughly with soap and water. on a clean, well-lit work surface, place the: - new autoinjector - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container d prepare and clean your injection site. you can use: - your thigh - stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) clean your injection site with an alcohol wipe. let your skin dry. - do not fan or blow on the clean area. - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the injection site you used the last time. do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - if you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not inject through your clothes. step 2: get ready e pull yellow cap straight off, only when you are ready to inject. it is normal to see a drop of liquid at the end of the needle or yellow safety guard. - do not twist or bend the yellow cap. - do not put the yellow cap back onto the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. f stretch or pinch your injection site to create a firm surface. stretch method stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches wide. pinch method pinch the skin firmly between your thumb and fingers, creating an area about 2 inches wide. important: keep the skin stretched or pinched while injecting. step 3: inject g hold the stretch or pinch. with the yellow cap off, place the autoinjector on your skin at 90 degrees. h firmly push the autoinjector down onto skin until it stops moving. push down important: you must push all the way down but do not touch blue start button until you are ready to inject. i when you are ready to inject, press the blue start button. j keep pushing down on your skin. your injection could take about 10 seconds. window turns yellow when injection is done important: when you remove the autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. call your doctor immediately. step 4: finish k discard (throw away) the used autoinjector and the yellow cap. - put the used sureclick autoinjector in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the sureclick autoinjector in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not reuse the autoinjector. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. important: always keep the sharps disposal container out of the reach of children. l examine the injection site. if there is blood, press a cotton ball or gauze pad on your injection site. do not rub the injection site. apply an adhesive bandage if needed. please see the medication guide for amjevita and accompanying prescribing information. commonly asked questions what will happen if i press the blue start button before i am ready to do the injection on my skin? can i move the autoinjector around on my skin while i am choosing an injection site? can i release the blue start button after i start my injection? will the blue start button pop up after i release my thumb? what do i do if i didn't hear a click after pushing the device down on my skin for 10 seconds? whom do i contact if i need help with the autoinjector or my injection? this instructions for use has been approved by the u.s. food and drug administration. manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 © 2022 amgen inc. all rights reserved. 1xxxxxx revised: 07/2022 v2 turn over to continue……… welcome! amjevita™ is supplied as a single-dose prefilled syringe. consult your doctor if you have any questions about your dose. your doctor has prescribed amjevita prefilled syringe for your injections. if your doctor decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your doctor or nurse. please read all of the instructions before using the amjevita prefilled syringe. call your doctor if you or your caregiver have any questions about the right way to inject amjevita. instructions for use amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use single-dose prefilled amjevita syringe guide to parts important: the needle is covered by the needle cap before use. important before you use an amjevita prefilled syringe, read this important information: storing your amjevita prefilled syringes - keep the amjevita prefilled syringe and all medicines out of the reach of children. - keep the amjevita prefilled syringe in the original carton to protect from light or physical damage. - the amjevita prefilled syringe should be kept in the refrigerator at 36° f to 46° f (2° c to 8° c). - if needed, you may store the amjevita prefilled syringe at room temperature up to 77° f (25° c) for up to 14 days. throw away amjevita if it has been kept at room temperature and has not been used within 14 days. - do not store the amjevita prefilled syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. - do not freeze. using your amjevita prefilled syringe - it is important that you do not try to give the injection unless you or your caregiver has received training from your doctor or nurse. - do not use the amjevita prefilled syringe after the expiration date on the label. - do not shake the amjevita prefilled syringe. - do not remove the needle cap from the amjevita prefilled syringe until you are ready to inject. - do not use the amjevita prefilled syringe if it has been frozen. - do not use the amjevita prefilled syringe if it has been dropped on a hard surface. part of the amjevita prefilled syringe may be broken even if you cannot see the break. use a new amjevita prefilled syringe, and call 1-800-77-amgen (1-800-772-6436). - the amjevita prefilled syringe is not made with natural rubber latex. - for more information or help call 1-800-77-amgen (1-800-772-6436). step 1: prepare a   remove the prefilled syringe carton from the refrigerator. remove the number of amjevita prefilled syringes you need for your injection from the carton. grab the syringe barrel to remove the prefilled syringe from the tray as shown. put the original carton with any unused prefilled syringes back in the refrigerator. for safety reasons: - do not grab the plunger rod. - do not grab the needle cap. - do not remove the needle cap until you are ready to inject. - do not remove the finger flange. the finger flange is part of the syringe. for a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before injecting. - do not put the syringe back in the refrigerator once it has reached room temperature. - do not try to warm the syringe by using a heat source such as hot water or microwave. - do not leave the syringe in direct sunlight. - do not shake the syringe. important: always hold the prefilled syringe by the syringe barrel. b   inspect the amjevita prefilled syringe. always hold the syringe by the syringe barrel. make sure the medicine in the syringe is clear and colorless to slightly yellow. - do not use the syringe if: the medicine is cloudy or discolored, or contains flakes or particles. any part appears cracked or broken. the needle cap is missing or not securely attached. the expiration date printed on the label has passed. - the medicine is cloudy or discolored, or contains flakes or particles. - any part appears cracked or broken. - the needle cap is missing or not securely attached. - the expiration date printed on the label has passed. in all cases, use a new syringe, and call 1-800-77-amgen (1-800-772-6436). c   gather all materials needed for your injection(s). wash your hands thoroughly with soap and water. on a clean, well-lit work surface, place the: - new syringe(s) - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container d   prepare and clean your injection site(s).          you can use: - your thigh - stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) clean your injection site with an alcohol wipe. let your skin dry. - do not fan or blow on the clean area. - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you need to use the same injection site, make sure it is not the same spot on the injection site you used the last time. do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - if you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not inject through your clothes. step 2: get ready e   hold the prefilled syringe by the syringe barrel with the needle cap pointing up. carefully pull the needle cap straight off and away from your body when you are ready to inject. it is normal to see a drop of liquid at the end of the needle. - do not twist or bend the needle cap. - do not put the needle cap back onto the syringe. - do not remove the needle cap from the syringe until you are ready to inject. important: throw the needle cap into the sharps disposal container provided. f   pinch your injection site to create a firm surface. pinch the skin firmly between your thumb and fingers, creating an area about 2 inches wide. important: keep the skin pinched while injecting. step 3: inject g   hold the pinch. with the needle cap off, insert the syringe into your skin at 45 to 90 degrees. do not place your finger on the plunger rod while inserting the needle. h   using slow and constant pressure, push the plunger rod all the way down until it reaches the bottom. do not pull back the plunger rod while the needle is inserted. i   when done, release your thumb, and gently pull the syringe off of your skin. step 4: finish j   discard (throw away) the used prefilled syringe and the needle cap. do not use any medicine that is left in the used syringe. - put the used amjevita prefilled syringe in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the prefilled syringe in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not reuse the syringe. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. important: always keep the sharps disposal container out of the reach of children. k   examine the injection site. if there is blood, press a cotton ball or gauze pad on your injection site. do not rub the injection site. apply an adhesive bandage if needed. please see the medication guide for amjevita and accompanying prescribing information. this instructions for use has been approved by the u.s. food and drug administration. manufactured by : amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 © 2022 amgen inc. all rights reserved. 1xxxxxx revised: 7/2022 v2 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) 10 mg/0.2 ml injection, for subcutaneous use single-dose prefilled syringe this instructions for use contains information on how to inject amjevita with a prefilled syringe. if your healthcare provider decides that a caregiver may be able to give your injections of amjevita at home, they should receive training on the right way to prepare and inject amjevita. do not try to inject until they have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita prefilled syringe is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the syringe if the carton is damaged or the seal is broken. - do not use the syringe after the expiration date on the label. - do not shake the syringe. - do not remove the needle cap from the syringe until you are ready to inject. - do not use the syringe if it has been frozen. - do not use the syringe if it has been dropped on a hard surface. part of the syringe may be broken even if you cannot see the break. use a new syringe, and call 1-800-77-amgen (1-800-772-6436). - the syringe is not made with natural rubber latex.   important: keep the syringe and sharps disposal container out of the sight and reach of children. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com, or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the syringe carton until you are ready to use it. - keep the syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the syringe in the original carton to protect it from light or physical damage. - do not freeze the syringe. - do not store the syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. important: keep the syringe out of the sight and reach of children. 2b grasp the syringe by the body and remove it from the carton. - do not grab the finger grip, plunger rod, or the needle cap. - remove the number of syringes you need for your injection. - put any unused syringes back into the refrigerator. 2c wait 15 to 30 minutes for the syringe to reach room temperature. - let the syringe warm up naturally. - do not heat the syringe with hot water, a microwave or direct sunlight. - do not shake the syringe at any time. - using the syringe at room temperature allows for a more comfortable injection. 2d you may keep amjevita at room temperature for up to 14 days, if needed. - for example when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68° f to 77° f (20° c to 25° c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68° f to 77° f (20° c to 25° c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2e gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita syringe (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3. getting ready for your injection 3a inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the syringe. - do not use amjevita if the medicine is cloudy, discolored or has flakes. 3b check the expiration date (exp.) and inspect the syringe for damage. - do not use the syringe if the expiration date has passed. - do not use the syringe if: the needle cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the needle cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3c inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3d wash hands thoroughly with soap and water. 3e clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a pull the needle cap straight off while holding the syringe body. - do not twist or bend the needle cap. - never put the needle cap back on. it may damage the needle. - do not let anything touch the needle after you remove the needle cap. - do not place the uncapped syringe on any surface after you remove the needle cap. - do not try to push air bubbles out of the syringe. it is okay to see air bubbles. - it is normal to see a drop of medicine come out of the needle. 4b place the needle cap in the sharps disposal container. 4c pinch the skin around the injection site before injection. - pinch the skin between the thumb and pointer (index) finger to create a bump for injection. - if possible, the bump should be about 2 inches wide. 4d insert the needle into the pinched skin at about a 45-degree angle. - do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine. 4e slowly press the plunger rod all the way down until it reaches the bottom to inject the medicine. - do not pull back on the plunger rod at any time. - do not remove the syringe until all of the medicine has been injected. 5. disposing of amjevita and checking the injection site 5a place the used syringe in an fda-cleared sharps disposal container right away after use. - do not reuse the syringe. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on the injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the us food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 04/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 40 mg/0.4 ml single-dose prefilled sureclick® autoinjector this instructions for use contains information on how to inject amjevita with a sureclick autoinjector. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita autoinjector is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the autoinjector if the carton is damaged or the seal is broken. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. - do not use the autoinjector if it has been frozen. - do not use the autoinjector if it has been dropped on a hard surface. part of the autoinjector may be broken even if you cannot see the break. use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the autoinjector is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the autoinjector carton until you are ready to use it. - keep the autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the autoinjector in the original carton to protect it from light or physical damage. - do not freeze the autoinjector. - do not store the autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b wait 15 to 30 minutes for the autoinjector to reach room temperature. - remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator. - let the autoinjector warm up naturally. - do not heat the autoinjector with hot water, a microwave, or direct sunlight. - do not shake the autoinjector at any time. - using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection. 2c you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2d inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the autoinjector. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 2e check the expiration date (exp.) and inspect the autoinjector for damage. - do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if: the yellow cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the yellow cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3. getting ready for your injection 3a gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita autoinjector (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3b inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3c wash hands thoroughly with soap and water. 3d clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a grasp the autoinjector so you can see the window. pull the yellow cap straight off. you may need to pull hard. - do not twist, bend or wiggle the yellow cap to pull it off. - never put the yellow cap back on. it may damage the needle. - do not put your finger inside the cream safety guard. - it is normal to see a drop of medicine at the end of the needle or cream safety guard. 4b pinch the skin to create a firm surface at the injection site. place the cream safety guard straight against the pinched skin. - keep the skin pinched until the injection is finished. - make sure you can see the window. - make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle). 4c firmly push the autoinjector down until the cream safety guard stops moving. hold the autoinjector down, do not lift. - the cream safety guard pushes in and unlocks the light blue start button. 4d keep pushing the autoinjector down and press the light blue start button to start the injection. - you may hear or feel a click. - the window starts to turn yellow. - it is okay to let go of the light blue start button. 4e keep pushing the autoinjector down. when the window is fully yellow, the injection is complete. - the injection may take up to 10 seconds to complete. - you may hear or feel a click. - lift the autoinjector away from your skin. - the cream safety guard locks around the needle. 5. disposing of amjevita and checking the injection site 5a place the used autoinjector and yellow cap in an fda-cleared sharps disposal container right away after use. - do not reuse the autoinjector. - do not touch the cream safety guard. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 80 mg/0.8 ml single-dose prefilled sureclick® autoinjector this instructions for use contains information on how to inject amjevita with a sureclick autoinjector. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita autoinjector is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the autoinjector if the carton is damaged or the seal is broken. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the yellow cap from the autoinjector until you are ready to inject. - do not use the autoinjector if it has been frozen. - do not use the autoinjector if it has been dropped on a hard surface. part of the autoinjector may be broken even if you cannot see the break. use a new autoinjector, and call 1-800-77-amgen (1-800-772-6436). - the autoinjector is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the autoinjector carton until you are ready to use it. - keep the autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the autoinjector in the original carton to protect it from light or physical damage. - do not freeze the autoinjector. - do not store the autoinjector in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b wait 15 to 30 minutes for the autoinjector to reach room temperature. - remove the number of autoinjectors you need for your injection and put any unused autoinjectors back into the refrigerator. - let the autoinjector warm up naturally. - do not heat the autoinjector with hot water, a microwave, or direct sunlight. - do not shake the autoinjector at any time. - using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection. 2c you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2d inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the autoinjector. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 2e check the expiration date (exp.) and inspect the autoinjector for damage. - do not use the autoinjector if the expiration date has passed. - do not use the autoinjector if: the yellow cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the yellow cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3. getting ready for your injection 3a gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita autoinjector (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3b inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3c wash hands thoroughly with soap and water. 3d clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a grasp the autoinjector so you can see the window. pull the yellow cap straight off. you may need to pull hard. - do not twist, bend or wiggle the yellow cap to pull it off. - never put the yellow cap back on. it may damage the needle. - do not put your finger inside the cream safety guard. - it is normal to see a drop of medicine at the end of the needle or cream safety guard. 4b pinch the skin to create a firm surface at the injection site. place the cream safety guard straight against the pinched skin. - keep the skin pinched until the injection is finished. - make sure you can see the window. - make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle). 4c firmly push the autoinjector down until the cream safety guard stops moving. hold the autoinjector down, do not lift. - the cream safety guard pushes in and unlocks the light blue start button. 4d keep pushing the autoinjector down and press the light blue start button to start the injection. - you may hear or feel a click. - the window starts to turn yellow. - it is okay to let go of the light blue start button. 4e keep pushing the autoinjector down. when the window is fully yellow, the injection is complete. - the injection may take up to 15 seconds to complete. - you may hear or feel a click. - lift the autoinjector away from your skin. - the cream safety guard locks around the needle. 5. disposing of amjevita and checking the injection site 5a place the used autoinjector and yellow cap in an fda-cleared sharps disposal container right away after use. - do not reuse the autoinjector. - do not touch the cream safety guard. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023 amjevita™ (am-jeh-vee'-tah) (adalimumab-atto) injection, for subcutaneous use 20 mg/0.2 ml 40 mg/0.4 ml 80 mg/0.8 ml single-dose prefilled syringe this instructions for use contains information on how to inject amjevita with a prefilled syringe. if your healthcare provider decides that you or a caregiver may be able to give your injections of amjevita at home, you should receive training on the right way to prepare and inject amjevita. do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse. the medicine in the amjevita prefilled syringe is for injection under the skin (subcutaneous injection). see the amjevita medication guide for information about amjevita. 1. important information you need to know before injecting amjevita dosing: - amjevita comes in 3 different doses: 20 mg/0.2 ml, 40 mg/0.4 ml, and 80 mg/0.8 ml. check your prescription to make sure you have the correct dose. - the color and look of the prefilled syringe will be different for each dose. the amount of medicine in the syringe will also be different for each dose. - for example, it is okay for the 20 mg/0.2 ml dose to have a small amount of medicine and the 80 mg/0.8 ml to have a large amount of medicine. check the illustrations below to see what your dose looks like in the syringe. 20 mg/0.2 ml 40 mg/0.4 ml 80 mg/0.8 ml - it is important that you do not try to give the injection until you have fully read and understood this instructions for use. - do not use the syringe if the carton is damaged or the seal is broken. - do not use the syringe after the expiration date on the label. - do not shake the syringe. - do not remove the needle cap from the syringe until you are ready to inject. - do not use the syringe if it has been frozen. - do not use the syringe if it has been dropped on a hard surface. part of the syringe may be broken even if you cannot see the break. use a new syringe, and call 1-800-77-amgen (1-800-772-6436). - the syringe is not made with natural rubber latex. frequently asked questions: for additional information and answers to frequently asked questions, visit www.amjevita.com . where to get help: if you want more information or help using amjevita: - contact your healthcare provider, - visit www.amjevita.com , or - call 1-800-77-amgen (1-800-772-6436) 2. storing and preparing to inject amjevita 2a refrigerate the syringe carton until you are ready to use it. - keep the syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the syringe in the original carton to protect it from light or physical damage. - do not freeze the syringe. - do not store the syringe in extreme heat or cold. for example, avoid storing in your vehicle's glove box or trunk. 2b grasp the syringe by the body and remove it from the carton. - do not grab the finger grip, plunger rod, or the needle cap. - remove the number of syringes you need for your injection. - put any unused syringes back into the refrigerator. 2c wait 15 to 30 minutes for the syringe to reach room temperature. - let the syringe warm up naturally. - do not heat the syringe with hot water, a microwave, or direct sunlight. - do not shake the syringe at any time. - using the syringe at room temperature allows for a more comfortable injection. 2d you may keep amjevita at room temperature for up to 14 days, if needed. - for example, when you are traveling, you may keep amjevita at room temperature. keep it at room temperature between 68°f to 77°f (20°c to 25°c). do not put it back in the refrigerator. record the date you removed it from the refrigerator and use it within 14 days. - keep it at room temperature between 68°f to 77°f (20°c to 25°c). - do not put it back in the refrigerator. - record the date you removed it from the refrigerator and use it within 14 days. 2e gather and place the following items for your injection on a clean, flat, and well-lit surface: - amjevita syringe (room temperature) - sharps disposal container [see disposing of amjevita and checking the injection site] - alcohol wipe - adhesive bandage - cotton ball or gauze pad 3. getting ready for your injection 3a inspect the medicine. it should be clear and colorless to pale yellow. - it is okay to see air bubbles in the syringe. - do not use amjevita if the medicine is cloudy, discolored, or has flakes or particles. 3b check the expiration date (exp.) and inspect the syringe for damage. - do not use the syringe if the expiration date has passed. - do not use the syringe if: the needle cap is missing or loose. it has cracks or broken parts. it has been dropped on a hard surface. - the needle cap is missing or loose. - it has cracks or broken parts. - it has been dropped on a hard surface. - make sure you have the right medicine and dose. 3c inject into 1 of these locations. - inject into the front of your thigh or stomach (except for 2 inches around your belly button). - choose a different site for each injection. 3d wash hands thoroughly with soap and water. 3e clean the injection site with an alcohol wipe. - let the skin dry on its own. - do not touch this area again before injecting. 4. injecting amjevita 4a pull the needle cap straight off while holding the syringe body. - do not twist or bend the needle cap. - never put the needle cap back on. it may damage the needle. - do not let anything touch the needle after you remove the needle cap. - do not place the uncapped syringe on any surface after you remove the needle cap. - do not try to push air bubbles out of the syringe. it is okay to see air bubbles. - it is normal to see a drop of medicine come out of the needle. 4b place the needle cap in the sharps disposal container. 4c pinch the skin around the injection site before injection. - pinch the skin between the thumb and pointer (index) finger to create a bump for the injection. - if possible, the bump should be about 2 inches wide. 4d insert the needle into the pinched skin at a 45-degree angle. - do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine. 4e slowly press the plunger rod all the way down until it reaches the bottom of the syringe to inject the medicine. - do not pull back on the plunger rod at any time. - do not remove the syringe until all of the medicine has been injected. 5. disposing of amjevita and checking the injection site 5a place the used syringe in an fda-cleared sharps disposal container right away after use. - do not reuse the syringe. 5b check the injection site. - do not rub the injection site. - if there is blood, press a cotton ball or gauze pad on your injection site. apply an adhesive bandage if necessary. additional information about your sharps disposal container if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. disposing of sharps disposal containers: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for more information or help call 1-800-77-amgen (1-800-772-6436). this instructions for use has been approved by the u.s. food and drug administration. amjevita (adalimumab-atto) manufactured by: amgen inc. one amgen center drive thousand oaks, california 91320-1799 us license number 1080 ©2023 amgen inc. all rights reserved. nnnnnnnnnn issued: 8/2023

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

celltrion usa, inc. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - yuflyma is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. yuflyma can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). yuflyma is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. yuflyma can be used alone or in combination with methotrexate. yuflyma is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. yuflyma can be used alone or in combination with non-biologic dmards. yuflyma is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. yuflyma is indicated for the treatment of moderately to severely active crohn's disease in adults and pediatric patients 6 years of age and older. yuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies (14.7)] . yuflyma is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. yuflyma should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions (5)] . yuflyma is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. yuflyma is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn's disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease- matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data) . adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see clinical considerations) . in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester [see data] . risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 mcg/ml in cord blood, 4.28-17.7 mcg/ml in infant serum, and 0-16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for yuflyma and any potential adverse effects on the breastfed child from yuflyma or from the underlying maternal condition. the safety and effectiveness of yuflyma have been established for: - reducing signs and symptoms of moderately to severely active polyarticular jia in pediatric patients 2 years of age and older. - the treatment of moderately to severely active crohn's disease in pediatric patients 6 years of age and older. pediatric assessments for yuflyma demonstrate that yuflyma is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, yuflyma is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, yuflyma was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to < 4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of yuflyma in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of yuflyma have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn's disease the safety and effectiveness of yuflyma for the treatment of moderately to severely active crohn's disease have been established in pediatric patients 6 years of age and older. use of yuflyma for this indication is supported by yuflyma's approval as a biosimilar to adalimumab and evidence from adequate and well-controlled studies in adults with additional data of adalimumab from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of yuflyma have not been established in pediatric patients with crohn's disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of yuflyma in patients 65 years of age and older. in patients treated with yuflyma, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2) ]. for subcutaneous use only read and follow the instructions for use that come with your yuflyma auto-injector before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or treatment. important information - use the auto-injector only if your doctor has trained you on the right way to prepare for and to give an injection. - ask your doctor how often you will need to give an injection. - do not shake the auto-injector at any time. - do not remove the cap until you are ready to inject. - do not share the auto-injector with anyone. how to store the auto-injector - store the auto-injector in a refrigerator between 36°f to 46°f (2°c to 8°c). - keep the auto-injector in the original carton until use to protect it from light. - do not use an auto-injector that has been left in direct sunlight. - do not freeze the auto-injector. if the auto-injector has been frozen, do not use the auto-injector even if it is thawed. - if needed, you may store the auto-injector at room temperature up to 77°f (25°c) for up to 31 days. - after the auto-injector has reached room temperature, do not put it back in the refrigerator. - keep the auto-injector and all medicines out of the reach of children. read instructions on all pages before using the yuflyma auto-injector prepare for injection - do not  use the auto-injector if;-it is cracked or damaged.-the expiration date has passed. figure b - do not use the auto-injector if the liquid is the discolored (yellow or dark brown), cloudy, or contains particles in it. - you may see air bubbles in the liquid. this is normal. figure c - do not warm the auto-injector using heat sources such as hot water or a microwave. figure d - do not inject into skin that is within 2 in (5 cm) of your belly button (navel), or is red, hard, tender, damaged, bruised, or scarred. - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. - do not inject the same injection site each time you give an injection. - each new injection site should be at least 1.2 in (3 cm) away from the injection site you used before. figure e figure f - do not blow on or touch the injection site again before giving the injection. figure g - do not recap the auto-injector. - do not remove the cap until you are ready to inject. - do not touch the needle or needle cover. doing so may result in a needle stick injury because the needle is inside the needle cover. figure h figure i - when the injection starts you will hear the 1st loud "click" and the blue plunger rod will begin to fill the window. - do not change the position of the auto-injector after the injection has started. figure j - after you remove the auto-injector from the injection site, the needle will be automatically covered (see figure l ). - if the window has not turned completely blue or if the medicine is still injecting, this means you have not received a full dose. call your doctor immediately. - you may see grey stopper in the window. this is normal. - some bleeding may occur. - do not reuse the auto-injector. - do not rub the injection site. figure k figure l - do not throw away (dispose of) the auto-injector in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is:-made of a heavy-duty plastic,-can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,-upright and stable during use,-leak-resistant, and-properly labeled to warn of hazardous waste inside the container. figure m - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for subcutaneous use only read and follow the instructions for use that come with your yuflyma prefilled syringe before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or treatment. important information - use the prefilled syringe with needle guard only if your doctor has trained you on the right way to prepare for and to give an injection. - ask your doctor how often you will need to give an injection. - do not shake the prefilled syringe at any time. - do not remove the cap until you are ready to inject. - do not share the prefilled syringe with anyone. - only use each prefilled syringe for one injection. - do not pull back on the plunger rod at any time. how to store the prefilled syringe - store the prefilled syringe in a refrigerator between 36°f to 46°f (2°c to 8°c). - keep the prefilled syringe in the original carton to protect it from light. - do not use a prefilled syringe that has been left in direct sunlight. - do not freeze the prefilled syringe. if the prefilled syringe has been frozen, do not use the prefilled syringe even if it is thawed. - if needed, you may store the prefilled syringe at room temperature up to 77°f (25°c) for up to 31 days. - after the prefilled syringe has reached room temperature, do not put it back in the refrigerator. - keep the prefilled syringe and all medicines out of the reach of children. read instructions on all pages before using the yuflyma prefilled syringe prepare for injection - hold the prefilled syringe body when removing it from the carton. do not touch the plunger rod. - do not  use the prefilled syringe if;-it is cracked or damaged.-the expiration date has passed. figure b - do not use the prefilled syringe if the liquid is the discolored (yellow or dark brown), cloudy, or contains particles in it. - you may see air bubbles in the liquid. this is normal. figure c - do not warm the prefilled syringe using heat sources such as hot water or a microwave. figure d - do not inject into skin that is within 2 in (5 cm) of your belly button (navel), or is red, hard, tender, damaged, bruised, or scarred. - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. figure e figure f - do not blow on or touch the injection site again before giving the injection. figure g - do not pull back on the plunger rod at any time. - do not recap the prefilled syringe. - do not remove the cap until you are ready to inject. - do not touch the needle. doing so may result in a needle stick injury. figure h - do not change the position of the prefilled syringe after the injection has started. figure i figure j - some bleeding may occur. - do not reuse the prefilled syringe. - do not touch or recap the needle. - do not rub the injection site. figure k - do not throw away (dispose of) the prefilled syringe in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is:-made of a heavy-duty plastic,-can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,-upright and stable during use,-leak-resistant, and-properly labeled to warn of hazardous waste inside the container. figure l - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. for subcutaneous use only read and follow the instructions for use that come with your yuflyma prefilled syringe before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or treatment. important information - use the prefilled syringe only if your doctor has trained you on the right way to prepare for and to give an injection. - ask your doctor how often you will need to give an injection. - do not shake the prefilled syringe at any time. - do not remove the cap until you are ready to inject. - do not share the prefilled syringe with anyone. - do not pull back on the plunger rod at any time. how to store the prefilled syringe - store the prefilled syringe in a refrigerator between 36°f to 46°f (2°c to 8°c). - keep the prefilled syringe in the original carton to protect it from light. - do not use a prefilled syringe that has been left in direct sunlight. - do not freeze the prefilled syringe. if the prefilled syringe has been frozen, do not use the prefilled syringe even if it is thawed. - if needed, you may store the prefilled syringe at room temperature up to 77°f (25°c) for up to 31 days. - after the prefilled syringe has reached room temperature, do not put it back in the refrigerator. - keep the prefilled syringe and all medicines out of the reach of children. read instructions on all pages before using the yuflyma prefilled syringe prepare for injection - hold the prefilled syringe body when removing it from the carton. do not touch the plunger rod. - do not  use the prefilled syringe if;-it is cracked or damaged.-the expiration date has passed. figure b - do not use the prefilled syringe if the liquid is the discolored (yellow or dark brown), cloudy, or contains particles in it. - you may see air bubbles in the liquid. this is normal. figure c - do not warm the prefilled syringe using heat sources such as hot water or a microwave. figure d - do not inject into skin that is within 2 in (5 cm) of your belly button (navel), or is red, hard, tender, damaged, bruised, or scarred. - if you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. - do not inject through your clothes. figure e figure f - do not blow on or touch the injection site again before giving the injection. figure g - do not pull back on the plunger rod at any time. - do not recap the prefilled syringe. - do not remove the cap until you are ready to inject. - do not touch the needle. doing so may result in a needle stick injury. figure h - do not change the position of the prefilled syringe after the injection has started. figure i figure j - some bleeding may occur. - do not reuse the prefilled syringe. - do not touch the needle. - do not rub the injection site. figure k - do not throw away (dispose of) the prefilled syringe in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is:-made of a heavy-duty plastic,-can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,-upright and stable during use,-leak-resistant, and-properly labeled to warn of hazardous waste inside the container. figure l - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

mylan specialty l.p. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - hulio is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. hulio can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). hulio is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. hulio can be used alone or in combination with methotrexate. hulio is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. hulio can be used alone or in combination with non-biologic dmards. hulio is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. hulio is indicated for the treatment of moderately to severely active crohn’s disease in adults and pediatric patients 6 years of age and older . hulio is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies (14.7, 14.8)] . hulio is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. hulio should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions (5)] . hulio is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients . hulio is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients . none. available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn’s disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data). adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see clinical considerations). in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester (see data) . risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see use in specific populations (8.4)] . a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 mcg/ml in cord blood, 4.28-17.7 mcg/ml in infant serum, and 0-16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for hulio and any potential adverse effects on the breastfed child from hulio or from the underlying maternal condition. the safety and effectiveness of hulio have been established for: pediatric assessments for hulio demonstrate that hulio is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, hulio is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero-exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn’s disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn’s disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of hulio in patients 65 years of age and older. in patients treated with hulio, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . for subcutaneous (under the skin) use only read these instructions carefully before using your pen. this information does not replace talking to your healthcare provider about your medical condition and your treatment. do not try to inject hulio yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your healthcare provider decides that you or a caregiver may be able to give your injections of hulio at home, you should receive training on the right way to prepare and inject hulio. it is important that you read, understand, and follow these instructions so that you inject hulio the right way. it is also important to talk to your healthcare provider to be sure you understand your hulio dosing instructions. to help you remember when to inject hulio, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver has any questions about the right way to inject hulio. for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) caution: never put your thumb, fingers, or hand over the orange activator after cap is removed. never press or push the orange activator with your thumb, fingers, or hand. the orange activator is where the needle comes out. if accidental injection to your fingers or hands occurs, apply first-aid and either call your healthcare provider or go to the nearest hospital emergency room if needed.   dosage: hulio pen is for single dose (1-time) use only. important: do not use hulio if frozen, even if it has been thawed. do not uncap your hulio pen until you are ready to inject and will not be interrupted. do not recap. recapping your hulio pen can damage the needle. a loud “click” will occur when the orange activator is pressed down to deliver your dose of hulio. parts of the hulio pen storing and handling the hulio pen if needed, for example when traveling, hulio may be stored at room temperature up to 77°f (25°c) for a period of up to 14 days, with protection from light. discard (throw away) hulio if not used within the 14-day period. record the date on the carton and dose tray when hulio is first removed from the refrigerator. gather supplies for injection find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive an injection. supplies you will need: included in hulio carton not included in hulio carton if you do not have all the supplies you need to give yourself an injection, visit or call your local pharmacist. preparing the pen remove the pen from the refrigerator 30 minutes before using. check the viewing window to make sure: do not use the pen if medicine is not near the fill marker. use another pen or contact your healthcare provider. do not use the pen if it is cloudy, discolored, or has particles in it. choosing and preparing injection site your healthcare provider should show you proper injection site techniques. giving the injection caution:  injection process must be completed without interruption. read all steps first before beginning injection. step 1 uncap important: step 2 squeeze and hold injection site the thigh injection site is shown here (see figure f). perform these steps the same way for abdomen (belly) injection sites.   step 3 place pen step 4 begin injection step 5 hold down for 2nd “click”, orange indicator and 10 seconds continue pushing the body of the pen down against the injection site until: caution: make sure all three of these have occurred to ensure all medicine was delivered. if the needle did not retract or you do not think you received the full dose, contact your healthcare provider for assistance. step 6 end of injection, remove hulio pen dispose of the hulio pen and cap put the used pen and cap in an fda-cleared sharps disposal container or puncture resistant container right away to avoid injury (see “how should i throw away (dispose of) the used hulio pen and cap?” in step 7). pen is for single-dose only. do not reuse the pen if all of the medicine was not injected. do not try to recap the pen as it could lead to a needle stick injury. step 7 how should i throw away (dispose of) the used hulio pen and cap? if you do not have an fda-cleared sharps disposal container, you may use a household container that is: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and pens. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. step 8 write down the date you received your injection and the injection site used in the injection diary. injection diary date injection site used           customer service for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) the brands listed are trademarks of their respective owners. hulio is a registered trademark of fujifilm kyowa kirin biologics co., ltd., licensed to the viatris companies. the hulio logo is a trademark of bgp products operations gmbh, a viatris company. © 2022 viatris inc. manufactured by: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured for: mylan specialty l.p. morgantown, wv 26505 u.s.a. u.s. license no. 2210 product of japan this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2022 pci:adal:ifup:rx6 697892 for subcutaneous (under the skin) use only read these instructions carefully before using your syringe. this information does not replace talking to your healthcare provider about your medical condition and your treatment. do not try to inject hulio yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your healthcare provider decides that you or a caregiver may be able to give your injections of hulio at home, you should receive training on the right way to prepare and inject hulio. it is important that you read, understand, and follow these instructions so that you inject hulio the right way. it is also important to talk to your healthcare provider to be sure you understand your hulio dosing instructions. to help you remember when to inject hulio, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver has any questions about the right way to inject hulio. for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) dosage: hulio prefilled syringe is for single dose (1-time) use only.   important: parts of the hulio prefilled syringe (syringe) see figure a storing and handling the syringe if needed, for example when traveling, hulio may be stored at room temperature up to 77°f (25°c) for a period of up to 14 days, with protection from light. discard (throw away) hulio if not used within the 14-day period. record the date on the carton and dose tray when hulio is first removed from the refrigerator. gather supplies for injection find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive an injection. supplies you will need: included in the hulio carton not included in hulio carton if you do not have all the supplies you need to give yourself an injection, visit or call your local pharmacist. preparing the syringe remove the syringe from the refrigerator 30 minutes before using. check the viewing window to make sure: do not use the syringe if medicine is not near the fill marker. use another syringe or contact your healthcare provider. do not use the syringe if it is cloudy, discolored, or has particles in it. choosing and preparing injection site your healthcare provider should show you proper injection site techniques. giving the injection caution:    injection process must be completed without interruption. read all steps first before beginning injection. step 1 uncap caution: step 2 squeeze and hold injection site the thigh injection site is shown here (see figure f). perform these steps the same way for abdomen (belly) injection sites. step 3 insert needle into site at a 45° angle to the injection site, with your other hand use a quick dart-like motion to insert the needle into the site (see figure g). be careful to insert the needle so that it will not inject into your fingers holding the injection site. step 4 inject medicine after the needle is in, let go of squeezing the injection site. slowly push the plunger all the way down with your thumb until all the medicine is injected and the syringe is empty (see figure h). if the plunger is not pressed all the way down the needle safety feature will not activate afterwards to cover the needle. do not move, twist, or rotate syringe during injection. step 5 end of injection, remove syringe pull the syringe away from the injection site, then release your thumb from the plunger. the needle will retract and the needle safety feature will cover the needle (see figure i). caution: if the needle did not retract or you do not think you received the full dose, contact your healthcare provider for assistance. if the needle does not retract, carefully place the syringe into a sharps or puncture resistant container to avoid injury. dispose of the hulio syringe and needle cap put the used syringe and needle cap in an fda-cleared sharps disposal container or puncture resistant container right away to avoid injury (see “how should i throw away (dispose of) the used hulio prefilled syringe and needle cap?” in step 6). syringe is for single-dose only. do not reuse the syringe even if all of the medicine was not injected. do not try to recap the needle as it could lead to a needle stick injury. step 6 how should i throw away (dispose of) the used hulio prefilled syringe and needle cap? if you do not have an fda-cleared sharps disposal container, you may use a household container that is: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. step 7 write down the date you received your injection and the injection site used in the injection diary. injection diary date injection site used             customer service for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) the brands listed are trademarks of their respective owners. hulio is a registered trademark of fujifilm kyowa kirin biologics co., ltd., licensed to the viatris companies. the hulio logo is a trademark of bgp products operations gmbh, a viatris company. © 2022 viatris inc. manufactured by: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured for: mylan specialty l.p. morgantown, wv 26505 u.s.a. u.s. license no. 2210 product of japan this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2022 pci:adal:ifus:rx5 697925

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

mylan specialty l.p. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - adalimumab-fkjp is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. adalimumab-fkjp can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). adalimumab-fkjp is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. adalimumab-fkjp can be used alone or in combination with methotrexate . adalimumab-fkjp is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. adalimumab-fkjp can be used alone or in combination with non-biologic dmards. adalimumab-fkjp is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. adalimumab-fkjp is indicated for the treatment of moderately to severely active crohn’s disease in adults and pediatric patients 6 years of age and older . adalimumab-fkjp is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. limitations of use the effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to tnf blockers [see clinical studies (14.7, 14.8)] . adalimumab-fkjp is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. adalimumab-fkjp should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see warnings and precautions (5)] . adalimumab-fkjp is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. hulio is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients . none. risk summary available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. clinical data are available from the organization of teratology information specialists (otis)/mothertobaby pregnancy registry in pregnant women with rheumatoid arthritis (ra) or crohn’s disease (cd) treated with adalimumab. registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with ra or cd and a rate of 7.5% for major birth defects in the disease matched comparison cohort. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see data) . adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see clinical considerations) . in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (mrhd) of 40 mg subcutaneous without methotrexate (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that the risk of adverse pregnancy outcomes in women with ra or inflammatory bowel disease (ibd) is associated with increased disease activity. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester (see data) . risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero  [see use in specific populations (8.4)] . data human data a prospective cohort pregnancy exposure registry conducted by otis/mothertobaby in the u.s. and canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 ra, 152 cd) treated with adalimumab during the first trimester and 106 women (74 ra, 32 cd) not treated with adalimumab. the proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% ra, 10.5% cd) and 7.5% (6.8% ra, 9.4% cd), respectively. the lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. this study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design. in an independent clinical study conducted in ten pregnant women with ibd treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. the last dose of adalimumab was given between 1 and 56 days prior to delivery. adalimumab concentrations were 0.16-19.7 mcg/ml in cord blood, 4.28-17.7 mcg/ml in infant serum, and 0-16.1 mcg/ml in maternal serum. in all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. in addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/ml), 7 weeks (1.31 mcg/ml), 8 weeks (0.93 mcg/ml), and 11 weeks (0.53 mcg/ml), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth. animal data in an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the mrhd without methotrexate (on an auc basis with maternal iv doses up to 100 mg/kg/week). adalimumab did not elicit harm to the fetuses or malformations. risk summary limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. however, the effects of local exposure in the gastrointestinal tract are unknown. there are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for adalimumab-fkjp and any potential adverse effects on the breastfed child from adalimumab-fkjp or from the underlying maternal condition. the safety and effectiveness of adalimumab-fkjp have been established for: pediatric assessments for adalimumab-fkjp demonstrate that adalimumab-fkjp is safe and effective for pediatric patients in indications for which humira (adalimumab) is approved. however, adalimumab-fkjp is not approved for such indications due to marketing exclusivity for humira (adalimumab). due to their inhibition of tnfα, adalimumab products administered during pregnancy could affect immune response in the in utero -exposed newborn and infant. data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see use in specific populations (8.1)] . the clinical significance of elevated adalimumab concentrations in infants is unknown. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. post-marketing cases of lymphoma, including hepatosplenic t-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with tnf-blockers including adalimumab products [see warnings and precautions (5.2)] . juvenile idiopathic arthritis in study jia-i, adalimumab was shown to reduce signs and symptoms of active polyarticular jia in patients 4 to 17 years of age [see clinical studies (14.2)] . in study jia-ii, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular jia [see adverse reactions (6.1)] . adalimumab products have not been studied in patients with polyarticular jia less than 2 years of age or in patients with a weight below 10 kg. the safety of adalimumab in patients in the polyarticular jia trials was generally similar to that observed in adults with certain exceptions [see adverse reactions (6.1)] . the safety and effectiveness of adalimumab products have not been established in pediatric patients with jia less than 2 years of age. pediatric crohn’s disease the safety and effectiveness of adalimumab products for the treatment of moderately to severely active crohn’s disease have been established in pediatric patients 6 years of age and older. use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see adverse reactions (6.1), clinical pharmacology (12.2, 12.3), clinical studies (14.6)] . the adverse reaction profile in patients 6 years to 17 years of age was similar to adults. the safety and effectiveness of adalimumab products have not been established in pediatric patients with crohn’s disease less than 6 years of age. a total of 519 ra patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies ra-i through iv. no overall difference in effectiveness was observed between these patients and younger patients. the frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. consider the benefits and risks of adalimumab-fkjp in patients 65 years of age and older. in patients treated with adalimumab-fkjp, closely monitor for the development of infection or malignancy [see warnings and precautions (5.1, 5.2)] . adalimumab-fkjp pen injection for subcutaneous use 40 mg/0.8 ml single-dose prefilled pen for subcutaneous (under the skin) use only read these instructions carefully before using your pen. this information does not replace talking to your healthcare provider about your medical condition and your treatment. do not try to inject adalimumab-fkjp yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your healthcare provider decides that you or a caregiver may be able to give your injections of adalimumab-fkjp at home, you should receive training on the right way to prepare and inject adalimumab-fkjp. it is important that you read, understand, and follow these instructions so that you inject adalimumab-fkjp the right way. it is also important to talk to your healthcare provider to be sure you understand your adalimumab-fkjp dosing instructions. to help you remember when to inject adalimumab-fkjp, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver has any questions about the right way to inject adalimumab-fkjp. for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) caution: never put your thumb, fingers, or hand over the orange activator after cap is removed. never press or push the orange activator with your thumb, fingers, or hand. the orange activator is where the needle comes out. if accidental injection to your fingers or hands occurs, apply first-aid and either call your healthcare provider or go to the nearest hospital emergency room if needed.   dosage: adalimumab-fkjp pen is for single dose (1-time) use only. important: do not use adalimumab-fkjp if frozen, even if it has been thawed. do not uncap your adalimumab-fkjp pen until you are ready to inject and will not be interrupted. do not recap. recapping your adalimumab-fkjp pen can damage the needle. a loud “click” will occur when the orange activator is pressed down to deliver your dose of adalimumab-fkjp. parts of the adalimumab-fkjp pen storing and handling the adalimumab-fkjp pen if needed, for example when traveling, adalimumab-fkjp may be stored at room temperature up to 77°f (25°c) for a period of up to 14 days, with protection from light. discard (throw away) adalimumab-fkjp if not used within the 14 day period. record the date on the carton and dose tray when adalimumab-fkjp is first removed from the refrigerator. gather supplies for injection find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive an injection. supplies you will need: included in adalimumab-fkjp carton not included in adalimumab-fkjp carton if you do not have all the supplies you need to give yourself an injection, visit or call your local pharmacist. preparing the pen remove the pen from the refrigerator 30 minutes before using. check the viewing window to make sure: do not use the pen if medicine is not near the fill marker. use another pen or contact your healthcare provider. do not use the pen if it is cloudy, discolored, or has particles in it. choosing and preparing injection site your healthcare provider should show you proper injection site techniques. giving the injection caution: injection process must be completed without interruption. read all steps first before beginning injection. step 1 uncap important: step 2 squeeze and hold injection site the thigh injection site is shown here (see figure f). perform these steps the same way for abdomen (belly) injection sites. step 3 place pen step 4 begin injection step 5 hold down for 2nd “click”, orange indicator and 10 seconds continue pushing the body of the pen down against the injection site until: caution: make sure all three of these have occurred to ensure all medicine was delivered. if the needle did not retract or you do not think you received the full dose contact your healthcare provider for assistance. step 6 end of injection, remove adalimumab-fkjp pen dispose of the adalimumab-fkjp pen and cap put the used pen and cap in an fda-cleared sharps disposal container or puncture resistant container right away to avoid injury (see “how should i throw away (dispose of) the used adalimumab-fkjp pen and cap?” in step 7). pen is for single-dose only. do not reuse the pen if all of the medicine was not injected. do not try to recap the pen as it could lead to a needle stick injury. step 7 how should i throw away (dispose of) the used adalimumab-fkjp pen and cap? if you do not have an fda-cleared sharps disposal container, you may use a household container that is: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and pens. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. step 8 write down the date you received your injection and the injection site used in the injection diary. injection diary date injection site used                     customer service for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) the brands listed are trademarks of their respective owners. the logo is a trademark of bgp products operations gmbh, a viatris company. © 2023 viatris inc. manufactured by: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured for: mylan specialty l.p. morgantown, wv 26505 u.s.a. u.s. license no. 2210 product of japan this instructions for use has been approved by the u.s. food and drug administration. revised: 06/2023 pci:adalub:ifup:r2 725787 adalimumab-fkjp injection for subcutaneous use 20 mg/0.4 ml and 40 mg/0.8 ml single-dose prefilled syringe for subcutaneous (under the skin) use only read these instructions carefully before using your syringe. this information does not replace talking to your healthcare provider about your medical condition and your treatment. do not try to inject adalimumab-fkjp yourself until you have been shown the right way to give the injections and have read and understand this instructions for use. if your healthcare provider decides that you or a caregiver may be able to give your injections of adalimumab-fkjp at home, you should receive training on the right way to prepare and inject adalimumab-fkjp. it is important that you read, understand, and follow these instructions so that you inject adalimumab-fkjp the right way. it is also important to talk to your healthcare provider to be sure you understand your adalimumab-fkjp dosing instructions. to help you remember when to inject adalimumab-fkjp, you can mark your calendar ahead of time. call your healthcare provider if you or your caregiver has any questions about the right way to inject adalimumab-fkjp. for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) dosage: adalimumab-fkjp prefilled syringe is for single dose (1-time) use only. important: parts of the adalimumab-fkjp prefilled syringe (syringe) see figure a storing and handling the syringe if needed, for example when traveling, adalimumab-fkjp may be stored at room temperature up to 77°f (25°c) for a period of up to 14 days, with protection from light. discard (throw away) adalimumab-fkjp if not used within the 14-day period. record the date on the carton and dose tray when adalimumab-fkjp is first removed from the refrigerator. gather supplies for injection find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive an injection. supplies you will need: included in the adalimumab-fkjp carton (taken from refrigerator 30 minutes prior to intended injection time to allow syringe to reach room temperature) not included in adalimumab-fkjp carton if you do not have all the supplies you need to give yourself an injection, visit or call your local pharmacist. preparing the syringe remove the syringe from the refrigerator 30 minutes before using. check the viewing window to make sure: do not use the syringe if medicine is not near the fill marker. use another syringe or contact your healthcare provider. do not use the syringe if it is cloudy, discolored, or has particles in it. choosing and preparing injection site your healthcare provider should show you proper injection site techniques. wait for it to dry on its own, do not fan or blow dry. giving the injection caution: injection process must be completed without interruption.               read all steps first before beginning injection. step 1 uncap caution: step 2 squeeze and hold injection site the thigh injection site is shown here (see figure f). perform these steps the same way for abdomen (belly) injection sites. step 3 insert needle into site at a 45° angle to the injection site, with your other hand use a quick dart-like motion to insert the needle into the site (see figure g). be careful to insert the needle so that it will not inject into your fingers holding the injection site. step 4 inject medicine after the needle is in, let go of squeezing the injection site. slowly push the plunger all the way down with your thumb until all the medicine is injected and the syringe is empty (see figure h). if the plunger is not pressed all the way down the needle safety feature will not activate afterwards to cover the needle. do not move, twist, or rotate syringe during injection. step 5 end of injection, remove syringe pull the syringe away from the injection site, then release your thumb from the plunger. the needle will retract and the needle safety feature will cover the needle (see figure i). caution : if the needle did not retract or you do not think you received the full dose, contact your healthcare provider for assistance. if the needle does not retract, carefully place the syringe into a sharps or puncture resistant container to avoid injury. dispose of the adalimumab-fkjp syringe and needle cap put the used syringe and needle cap in an fda-cleared sharps disposal container or puncture resistant container right away to avoid injury (see “how should i throw away (dispose of) the used adalimumab-fkjp prefilled syringe and needle cap?” in step 6). syringe is for single-dose only. do not reuse the syringe even if all of the medicine was not injected. do not try to recap the needle as it could lead to a needle stick injury. step 6 how should i throw away (dispose of) the used adalimumab-fkjp prefilled syringe and needle cap? if you do not have an fda-cleared sharps disposal container, you may use a household container that is: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. do not recycle your used sharps disposal container. step 7 write down the date you received your injection and the injection site used in the injection diary. injection diary date injection site used                          customer service for questions or assistance, call mylan at 1-877-446-3679 (1-877-4-info-rx) the brands listed are trademarks of their respective owners. the logo is a trademark of bgp products operations gmbh, a viatris company. © 2023 viatris inc. manufactured by: mylan pharmaceuticals inc. morgantown, wv 26505 u.s.a. manufactured for: mylan specialty l.p. morgantown, wv 26505 u.s.a. u.s. license no. 2210 product of japan this instructions for use has been approved by the u.s. food and drug administration. issued: 06/2023 pci:adalub:ifus:r2 725784

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

remedyrepack inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine injection, usp auto-injectors are indicated in the emergency treatment of allergic reactions (type i) including anaphylaxis to stinging insects (e.g., order hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. epinephrine injection, usp auto-injectors are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. epinephrine injection, usp auto-injectors are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care. none there are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. in animal reproductive studies, epinephrine administered by the subcutaneous route to rabbits, mice, and hamsters during the period of organogenesis was teratogenic at doses 7 times and higher than the maximum recommended human intramuscular and subcutaneous dose on a mg/m 2 basis. epinephrine is the first-line medication of choice for the treatment of anaphylaxis during pregnancy in humans. epinephrine should be used for treatment of anaphylaxis during pregnancy in the same manner as it is used in non-pregnant patients. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. during pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. the prevalence of anaphylaxis occurring during pregnancy is reported to be approximately 3 cases per 100,000 deliveries. management of anaphylaxis during pregnancy is similar to management in the general population. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in pregnant and non-pregnant patients. in conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. in an embryofetal development study with rabbits dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including gastroschisis and embryonic lethality) at doses approximately 40 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). in an embryofetal development study with mice dosed during the period of organogenesis, epinephrine was shown to be teratogenic (including embryonic lethality) at doses approximately 8 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). these effects were not seen in mice at approximately 4 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). in an embryofetal development study with hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine was shown to be teratogenic at doses approximately 7 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day). there is no information on the presence of epinephrine in human milk, the effects on breastfed infants, or the effects on milk production. epinephrine is the first line-medication of choice for treatment of anaphylaxis; it should be used in the same manner in breastfeeding and non-breastfeeding patients. epinephrine injection, usp auto-injector may be administered to pediatric patients at a dosage appropriate to body weight [ see dosage and administration (2.1) ] . clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. since the doses of epinephrine delivered from epinephrine injection, usp auto-injectors are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. however, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. therefore, epinephrine injection, usp auto-injector should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [ see warnings and precautions (5.5), overdosage (10) ]. epinephrine injection [/eh-puh-neh-fruhn/], usp auto-injector 0.3 mg one dose of 0.3 mg epinephrine, usp 0.3 mg/0.3 ml epinephrine injection [/eh-puh-neh-fruhn/], usp auto-injector 0.15 mg one dose of 0.15 mg epinephrine, usp 0.15 mg/0.3 ml authorized generic for epipen® and epipen jr® auto-injectors for allergic emergencies (anaphylaxis) read this patient information leaflet carefully before using the epinephrine injection, usp auto-injector and each time you get a refill. there may be new information. anyone who may be able to administer the epinephrine injection, usp auto-injector, should know how to use it before you have an allergic emergency. this information does not take the place of talking with your healthcare provider about your medical condition or your treatment. what is the most important information i should know about epinephrine injection, usp auto-injector? - epinephrine injection, usp auto-injector is a single-dose automatic injection devices (auto-injectors) that contains epinephrine. epinephrine is a medicine used to treat allergic emergencies (anaphylaxis). anaphylaxis can be life threatening and, can happen within minutes. if untreated, anaphylaxis can lead to death. this allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. symptoms of anaphylaxis may include: - trouble breathing - wheezing - hoarseness (changes in the way your voice sounds) - hives (raised reddened rash that may itch) - severe itching - swelling of your face, lips, mouth, or tongue - skin rash, redness, or swelling - fast heartbeat - weak pulse - feeling very anxious - confusion - stomach pain - losing control of urine or bowel movements (incontinence) - diarrhea or stomach cramps - dizziness, fainting, or “passing out” (unconsciousness) - always carry 2 epinephrine injection, usp auto-injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care. you also need to always carry 2 auto-injectors with you if the first auto-injector is activated before the dose can be given. a device that has been activated by accident cannot be used in an allergic emergency (anaphylaxis). - note: the epinephrine injection, usp auto-injector has been activated when the blue safety top is removed and a “pop” is heard, the orange needle end of the auto-injector is extended, or the medicine viewing window is blocked. - you may not know when anaphylaxis will happen. talk to your healthcare provider if you need more auto-injectors to keep at work, school, or other locations. if you use 1 epinephrine injection, usp auto-injector to treat an emergency allergic reaction, be sure to replace it so you always carry 2 auto-injectors. tell your family members, caregivers, and others where you keep your epinephrine injection, usp auto-injectors. make sure they know how to use it before you need it. you may be unable to speak in an allergic emergency. - when you have an allergic emergency (anaphylaxis) use epinephrine injection, usp auto-injector right away. - get emergency medical help right away even if you have used the epinephrine injection, usp auto-injector. you can use a second epinephrine injection, usp auto-injector if symptoms continue or come back or if the first auto-injector is activated before the dose can be given. for this reason, you should carry 2 epinephrine injection, usp auto-injectors with you at all times. if you need more than 2 doses for an allergic emergency, they must be given by a healthcare provider. what are epinephrine injection, usp auto-injectors? - epinephrine injection, usp auto-injectors are disposable, prefilled auto-injectors used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. each device contains one dose of epinephrine. - epinephrine injection, usp auto-injectors are for immediate administration by you or your caregiver. they do not take the place of emergency medical care. you should get emergency help right away after using your epinephrine injection, usp auto-injector. - epinephrine injection, usp auto-injectors are for people who have been prescribed this medicine by their healthcare provider. - the epinephrine injection, usp auto-injector (0.3 mg) is for people who weigh 66 pounds or more (30 kilograms or more). - the epinephrine injection, usp auto-injector (0.15 mg) is for people who weigh about 33 to 66 pounds (15 to 30 kilograms). - it is not known if epinephrine injection, usp auto-injector is safe and effective in children who weigh less than 33 pounds (15 kilograms). what should i tell my healthcare provider before using epinephrine injection, usp auto-injector? before you use your epinephrine injection, usp auto-injector, tell your healthcare provider about all your medical conditions. your healthcare provider may give you more instructions about when and how to use epinephrine injection, usp auto-injector if you have the following: - heart problems or high blood pressure - diabetes - thyroid problems - asthma - a history of depression - parkinson’s disease you may also receive more instructions if you: - are pregnant or plan to become pregnant. it is not known if epinephrine will harm your unborn baby. - are breastfeeding or plan to breastfeed. it is not known if epinephrine passes into your breast milk. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. tell your healthcare provider about all of your known allergies. especially tell your healthcare provider if you take certain asthma medicines. epinephrine injection, usp auto-injector and other medicines may affect each other, causing side effects. epinephrine injection, usp auto-injector may affect the way other medicines work. other medicines may affect how epinephrine injection, usp auto-injector works. know the medicines you take. keep a list of all your medicines, including over-the-counter medicines, vitamins and herbal supplements to show your healthcare provider and pharmacist when you get a new medicine. use your epinephrine injection, usp auto-injector for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicines you take. how should i use the epinephrine injection, usp auto-injector? - use your single-dose epinephrine injection, usp auto-injector exactly as your healthcare provider tells you to use it. you may need to use a second epinephrine injection, usp auto-injector if symptoms continue or come back while you wait for emergency help or if the first auto-injector is activated before the dose can be given. if you need more than 2 doses of epinephrine for a single anaphylaxis episode, more doses must be administered by a healthcare provider. - epinephrine injection, usp auto-injector should be injected into the middle of your outer thigh (upper leg). it can be injected through your clothing if needed. do not inject into a vein or into the buttocks, fingers, toes, hands or feet. - read and make sure you understand the instructions for use at the end of this patient information leaflet to learn the right way to use the epinephrine injection, usp auto-injector. - your healthcare provider will show you how to safely use the epinephrine injection, usp auto-injector. - it is very important that you hold the epinephrine injection, usp auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. if you do not hold it in place long enough, the epinephrine injection, usp auto-injector might not have time to deliver the correct dose of medicine. - caution: never put your thumb, fingers or hand over the orange needle end. never press or push the orange needle end with your thumb, fingers or hand. the needle comes out of the orange needle end. accidental injection into fingers, hands or feet may cause a loss of blood flow to these areas. if an accidental injection happens, go immediately to the nearest emergency room. - warning: do not flip the blue safety top off using a thumb or by pulling it sideways, or by bending and twisting the blue safety top. this may cause the device to activate by accident: a “pop” is heard, the orange needle end is extended and the medicine viewing window is blocked. a device that has been activated by accident cannot be used in an emergency. if this happens, replace it with a new epinephrine injection, usp auto-injector. - when you are ready to inject, pull the blue safety top straight up and away from the auto-injector. - your epinephrine injection, usp auto-injector may come in a package with a gray trainer and separate trainer instructions for use. the gray trainer contains no medicine and no needle. keep the trainer and the real epinephrine injection, usp auto-injector away from young children. the real epinephrine injection, usp auto-injector and trainer are not toys. for young children, use of the trainer and the real epinephrine injection, usp auto-injector should be supervised by an adult. regularly practice with your gray trainer in non-emergency situations to make sure you can safely use the real epinephrine injection, usp auto-injector in an emergency. always carry your 2 real epinephrine injection, usp auto-injectors with you in case of an allergic emergency. additional training information is available at www.epipen.com . - do not drop the protective case or epinephrine injection, usp auto-injector. if the protective case or auto-injector is dropped, check for damage and leakage. if damage or leakage is noticed or suspected, throw away (dispose of) the epinephrine injection, usp auto-injector and protective case and replace it. what are the possible side effects of epinephrine injection, usp auto-injectors? epinephrine injection, usp auto-injectors may cause serious side effects. - epinephrine injection, usp auto-injector should only be injected into the middle of your outer thigh (upper leg). do not inject the epinephrine injection, usp auto-injector into your: veins buttocks fingers, toes, hands or feet if you accidentally inject epinephrine injection, usp auto-injector into any place other than the middle of your outer thigh, go to the nearest emergency room right away. tell the healthcare provider where on your body you received the accidental injection. - veins - buttocks - fingers, toes, hands or feet if you accidentally inject epinephrine injection, usp auto-injector into any place other than the middle of your outer thigh, go to the nearest emergency room right away. tell the healthcare provider where on your body you received the accidental injection. if you accidentally inject epinephrine injection, usp auto-injector into any place other than the middle of your outer thigh, go to the nearest emergency room right away. tell the healthcare provider where on your body you received the accidental injection. - rarely, people who have used the epinephrine injection, usp auto-injector may get infections at the injection site within a few days of an injection. some of these infections can be serious. call your healthcare provider right away if you see any of the following at an injection site: redness that does not go away swelling tenderness the area feels warm to the touch - redness that does not go away - swelling - tenderness - the area feels warm to the touch - cuts on the skin, bent needles and needles that remain in the skin after the injection can happen when young children kick or move during an injection. if you inject a young child with an epinephrine injection, usp auto-injector, hold their leg firmly in place before and during the 3 second injection to prevent injuries. follow the instructions for use at the end of this patient information leaflet. ask your healthcare provider to show you how to: - hold the young child firmly in place (restrain). - with one hand, grip the auto-injector with the orange needle end pointing down. - with the other hand, pull the blue safety top straight up and away from the auto-injector. - if you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your epinephrine injection, usp auto-injector. talk to your healthcare provider about all your medical conditions. common side effects of epinephrine injection, usp auto-injectors include: - fast, irregular or “pounding” heartbeat - sweating - headache - weakness - shakiness - paleness - feelings of over excitement, nervousness or anxiety - dizziness - nausea or vomiting - breathing problems these side effects may go away with rest. tell your healthcare provider if you have any side effect that bothers you or that does not go away. these are not all the possible side effects of the epinephrine injection, usp auto-injector. for more information, ask your healthcare provider or pharmacist. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store epinephrine injection, usp auto-injectors? - store epinephrine injection, usp auto-injectors at room temperature between 68°f to 77°f (20°c to 25°c). - keep this medicine out of the sight and reach of young children. - keep protective case in the outer carton to protect from light. when exposed to air or light epinephrine changes quickly to a pinkish or brown color and should not be used. - do not expose to extreme cold or heat. for example, do not store in your vehicle’s glove box or trunk. do not store in the refrigerator or freezer. - examine the contents in the medicine viewing window of your epinephrine injection, usp auto-injector regularly. the medicine should be clear. if the medicine is discolored (pinkish or brown color) or contains solid particles, replace the auto-injector. - always keep your 2 epinephrine injection, usp auto-injectors in the protective cases to prevent damage to the device. the protective case is not waterproof. - the blue safety top helps to prevent accidental injection. keep the blue safety top in place until you need to use the epinephrine injection, usp auto-injector. after the auto-injector is used, throw away the blue safety top as this may pose a choking hazard for small children. disposing of an expired, unused or used epinephrine injection, usp auto-injector your epinephrine injection, usp auto-injector has an expiration date. replace the pack of auto-injectors before the expiration date. throw away (dispose of) expired, unwanted, or unused epinephrine injection, usp auto-injectors in an fda-cleared sharps disposal container right away after use. do not throw away the epinephrine injection, usp auto-injectors in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal visit the fda’s website (https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know) for more information about how to throw away unused, unwanted or expired medicines. after using your epinephrine injection, usp auto-injector in an allergic emergency, get emergency medical help right away. take your used epinephrine injection, usp auto-injector with you to give to your healthcare provider for disposal. general information about the safe and effective use of epinephrine injection, usp auto-injectors. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use the epinephrine injection, usp auto-injector for a condition for which it was not prescribed. do not give your epinephrine injection, usp auto-injector to other people. this patient information leaflet summarizes the most important information about the epinephrine injection, usp auto-injectors. if you would like more information, talk to your healthcare provider. you can ask your pharmacist or healthcare provider for information about epinephrine injection, usp auto-injectors that is written for health professionals. what are the ingredients in epinephrine injection, usp auto-injectors? active ingredients: epinephrine inactive ingredients: sodium chloride, sodium metabisulfite, hydrochloric acid, and water important information - the epinephrine injection, usp auto-injector, 0.3 mg has a yellow colored label. - the epinephrine injection, usp auto-injector, 0.15 mg has a green colored label. - your epinephrine injection, usp auto-injector is designed to work through clothing. - when receiving an epinephrine injection, usp auto-injector and before you need to use the epinephrine injection, usp auto-injector, remove the auto-injector from the protective case and check the auto-injector to make sure the blue safety top is not raised (see figure d in the instructions for use). if the blue safety top is raised, the auto-injector should not be used because the device could activate by accident. do not try to push the blue safety top back down. put the auto-injector back in the protective case and replace it with a new epinephrine injection, usp auto-injector. - choking hazard: the blue safety top is a small part that may become a choking hazard for children. throw away the blue safety top immediately after using epinephrine injection, usp auto-injector. - it is very important that you hold the epinephrine injection, usp auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. if you do not hold it in place long enough, the epinephrine injection, usp auto-injector might not deliver the correct dose of medicine. - if an accidental injection happens, get emergency medical help right away. - do not place patient information or any other foreign objects in the protective case with the epinephrine injection, usp auto-injector, as this may prevent you from removing the auto-injector for use. - each epinephrine injection, usp auto-injector can be used only 1 time (single-use). the auto-injectors deliver a fixed dose of epinephrine and cannot be reused. do not try to reuse epinephrine injection, usp auto-injector after the device has been activated. it is normal for most of the medicine to remain in the auto-injector after the dose is injected. the correct dose has been administered if the orange needle end is extended to cover the needle and the medicine viewing window is blocked. - incorrect use and correct use of epinephrine injection, usp auto-injector incorrect use correct use and important reminders storage outside the protective case or storage of the epinephrine injection, usp auto-injector in extreme cold or heat. always keep your epinephrine injection, usp auto-injector stored in the protective case and at room temperature. keep protective case in the outer carton to protect from light. wrong storage may stop the epinephrine injection, usp auto-injector from working. if the device has been in extreme cold or heat, the epinephrine injection, usp auto-injector should be replaced. failing to remove the auto-injector from the protective case before use. the epinephrine injection, usp auto-injector must be removed from the protective case it comes in before use. failing to remove the blue safety top before use. remove the blue safety top before use. epinephrine injection, usp auto-injector will not activate with the blue safety top in place. activating the auto-injector upside down which will cause an injection into the hand. the needle exits from the orange end of the epinephrine injection, usp auto-injector, which should be in contact with the outer thigh (upper leg) at a 90˚ angle (perpendicular) to the thigh before and during activation. the orange needle end will extend to cover the needle after activation. if you can still see the needle, do not try to reuse the auto-injector. failing to apply enough force to activate the epinephrine injection, usp auto-injector. epinephrine injection, usp auto-injector should be administered by swinging and pushing the auto-injector firmly against the outer thigh. epinephrine injection, usp auto-injectors make a distinct pop sound when pushed against the thigh. the pop sound signals that the injection has started. the correct dose has been administered if the orange needle end is extended and the window is blocked. administering at an injection site other than the outer thigh. administer epinephrine injection, usp auto-injector in the outer thigh only. failing to hold the auto-injector in place for a full 3 seconds. hold the epinephrine injection, usp auto-injector in place for a full 3 seconds following activation (count slowly 1, 2, 3). for more information and video instructions on the use of epinephrine injection, usp auto-injectors, go to www.epipen.com or call 1-800-395-3376. epinephrine injection [/eh-puh-neh-fruhn/], usp auto-injector 0.3 mg one dose of 0.3 mg epinephrine, usp 0.3 mg/0.3 ml for intramuscular and subcutaneous use epinephrine injection [/eh-puh-neh-fruhn/], usp auto-injector 0.15 mg one dose of 0.15 mg epinephrine, usp 0.15 mg/0.3 ml for intramuscular and subcutaneous use this instructions for use contains information on how to administer the epinephrine injection, usp auto-injector. important information you need to know before administering the epinephrine injection, usp auto-injector - the single-dose epinephrine injection, usp auto-injector is for allergic emergency (anaphylaxis) and should be used right away. you can use a second epinephrine injection, usp auto-injector if symptoms continue or symptoms come back. - before you need to use your epinephrine injection, usp auto-injector, make sure your healthcare provider shows you the right way to use it. anyone who may be able to administer the epinephrine injection, usp auto-injector should also understand how to use it. - carefully read the instructions for use in a non-emergency situation and make sure you understand them before using your epinephrine injection, usp auto-injector. - if you have any questions, ask your healthcare provider. - it is very important that you hold the epinephrine injection, usp auto-injector down for at least 3 full seconds. if you do not hold it in place long enough, the epinephrine injection, usp auto-injector might not have time to deliver the correct dose of medicine. - make sure to always carry 2 epinephrine injection, usp auto-injectors. one dose may not be enough. - inject epinephrine injection, usp auto-injector into the muscle (intramuscular) or under the skin (subcutaneous) in the middle of the outer thigh (see figure b ). do not inject epinephrine injection, usp auto-injector into any other part of the body. - the injection can be given through clothes. - each epinephrine injection, usp auto-injector can be used only 1 time (single-use). it is normal for most of the medicine to remain in the auto-injector after the dose is injected. the correct dose has been administered if the orange needle end is extended to cover the needle and the medicine viewing window is blocked. - warning: do not flip the blue safety top off using a thumb or by pulling it sideways, or by bending and twisting the blue safety top. this may cause the device to activate by accident: a “pop” is heard, the orange needle end is extended and the medicine viewing window is blocked. a device that has been activated by accident cannot be used in an emergency. if this happens, replace it with a new epinephrine injection, usp auto-injector. - do not take the epinephrine injection, usp auto-injector apart. - keep the blue safety top in place until you are ready to inject. - always point the orange needle end down (see figure c ). keep your fingers, thumb and hand away from the orange needle end. accidental injection in the fingers, thumb or feet may cause loss of blood flow to these areas. checking the blue safety top when receiving an epinephrine injection, usp auto-injector and before you need to use the epinephrine injection, usp auto-injector, do the following: - remove the epinephrine injection, usp auto-injector from the protective case and check the auto-injector to make sure the blue safety top is not raised (see figure d ). if the blue safety top is not raised, the auto-injector is okay to use. put the auto-injector back in the protective case so that it is ready to be used in an allergic emergency. - if the blue safety top is raised (see figure e), the auto-injector should not be used because the device could activate by accident. do not try to push the blue safety top back down. put the auto-injector back in the protective case and replace it with a new epinephrine injection, usp auto-injector. preparing to inject epinephrine injection, usp auto-injector note the following while preparing to inject epinephrine injection, usp auto-injector: - remove anything in or around the injection site that blocks you from giving the injection. - check the auto-injector before use. if the auto-injector appears damaged, throw it away (dispose of) and do not use. - the gray trainer contains no medicine and no needle. practice with the gray trainer before an allergic emergency happens to make sure you can safely use the real epinephrine injection, usp auto-injector in an emergency. - keep the trainer and the real epinephrine injection, usp auto-injectors away from young children. the epinephrine injection, usp auto-injectors and trainer are not toys. use by young children should be supervised by an adult. - while preparing to inject, make sure you know where to inject (see figure b ) and how to hold the epinephrine injection, usp auto-injector (see figure c ). - epinephrine injection, usp auto-injectors have a never-see-needle® that covers the needle before and after you inject (see figure g ). you should never see a needle. if you can see a needle, do not use the epinephrine injection, usp auto-injector. make sure the epinephrine injection, usp auto-injector has not been used. if an epinephrine injection, usp auto-injector has been used: - the orange needle end will be extended (see step 4 ), - the medicine viewing window will be blocked, and - the epinephrine injection, usp auto-injector will no longer fit in the protective case. preparing to inject a child - if you are giving epinephrine injection, usp auto-injector to a young child, first hold the child firmly in place (restrain) and then use both hands to remove the blue safety top as shown (see figure j ). use one hand to hold the auto-injector with the orange needle end pointing down and your other hand to remove the blue safety top to activate the auto-injector. then, inject in the middle of the outer thigh (see figure l ). remember to hold the leg firmly in place before and during the 3 second injection to avoid needlestick injuries including cuts to the thigh. - keep the trainer and the real epinephrine injection, usp auto-injectors away from young children. the real epinephrine injection, usp auto-injectors and trainer are not toys. use by young children should be supervised by an adult. checking the medicine color examine the liquid in the medicine viewing window of your epinephrine injection, usp auto-injector regularly. see the information below: medicine color: - the medicine can be seen through the medicine viewing window located near the middle of the epinephrine injection, usp auto-injector. - to check the medicine color, hold the auto-injector in front of a white background in a well-lit area and look through the medicine viewing window. figure h. medicine viewing window - use the medicine if it is clear and colorless. do not use the medicine if it is discolored (pinkish or brown color) or if the medicine has particles floating in it. throw it away (dispose of) and use a new epinephrine injection, usp auto-injector (see the section “disposing of an expired, unused or used epinephrine injection, usp auto-injector” on the patient information side of this leaflet). injecting epinephrine injection, usp auto-injector step 1 slide the epinephrine injection, usp auto-injector out of the case (figure i) remove the auto-injector from the protective case. step 2 pull off the blue safety top (figure j) grip the epinephrine injection, usp auto-injector with one hand and with the orange needle end pointing down. use the other hand to remove the blue safety top. pull it straight up and away. note: do not twist or bend the blue safety top. failure to pull out the blue safety top correctly (straight up and away) can cause accidental activation. note: to avoid an accidental injection, never put your thumb, fingers or hand over the orange needle end. if an accidental injection happens, get emergency medical help right away. step 3 inject the medicine by self (figure k) or caregiver (figure l) administration place the orange needle end against the outer thigh, through clothing if needed. push down firmly and hold in place for 3 seconds. note: epinephrine injection, usp auto-injectors make a distinct pop sound when pushed against the thigh. this is normal and means that the epinephrine injection, usp auto-injector is working. after the pop, continue to press the epinephrine injection, usp auto-injector down firmly on the outer thigh for 3 seconds to make sure that the medicine is given. step 4 check if used (figure m) lift the auto-injector straight out from the thigh. the orange needle end will extend to cover the needle. if the needle is visible, do not reuse it. use a new auto-injector. throw away the blue safety top. step 5 get emergency medical help after injecting epinephrine injection, usp auto-injector, get emergency medical help right away. you can use a second epinephrine injection, usp auto-injector if symptoms continue or come back. - take your used epinephrine injection, usp auto-injector to your healthcare provider. - epinephrine injection, usp auto-injectors are single-dose auto-injectors and cannot be reused. - if the needle is visible, do not try to reuse it. storing epinephrine injection, usp auto-injector store the epinephrine injection, usp auto-injectors at room temperature between 68˚ f to 77˚ f (20˚ c to 25˚ c). keep protective case in the outer carton to protect from light. when exposed to air or light, the medicine in the epinephrine injection, usp auto-injector changes rapidly to a pinkish or brown color and should not be used. disposing of epinephrine injection, usp auto-injector after using your epinephrine injection, usp auto-injector, get emergency medical help right away. take your used auto-injector with you to give to your healthcare provider for disposal. important: the blue safety top is a small part that may become a choking hazard for children. throw away the blue safety top immediately after using the epinephrine injection, usp auto-injector. your epinephrine injection, usp auto-injector has an expiration date. replace it before the expiration date. for more information on how to throw away (dispose of) your expired epinephrine injection, usp auto-injector, see the section “disposing of an expired, unused or used epinephrine injection, usp auto-injector” on the patient information side of this leaflet. manufactured for: mylan specialty l.p., morgantown, wv 26505, u.s.a. by meridian medical technologies, llc, st. louis, mo 63146, u.s.a. epipen® or epipen jr® are registered trademarks of mylan inc., a viatris company. copyright © 2022 meridian medical technologies. all rights reserved. ms:pil:epig:r7 0002190 this patient information and instructions for use have been approved by the u.s. food and drug administration. revised: 02/2023 epinephrine injection, usp auto-injector 0.3 mg one dose of 0.3 mg epinephrine, usp 0.3 mg/0.3 ml epinephrine injection, usp auto-injector 0.15 mg one dose of 0.15 mg epinephrine, usp 0.15 mg/0.3 ml for more information about epinephrine injection, usp auto-injectors and proper use of the product, call mylan at 1-877-446-3679 or visit www.epipen.com .

Airija - anglų - HPRA (Health Products Regulatory Authority)

accord healthcare limited - midazolam - solution for injection - 5 mg/ml - midazolam

Airija - anglų - HPRA (Health Products Regulatory Authority)

accord healthcare limited - midazolam - solution for injection - 1 milligram(s)/millilitre - benzodiazepine derivatives; midazolam