Ηνωμένες Πολιτείες - Αγγλικά - 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-

Ισραήλ - Αγγλικά - Ministry of Health

padagis israel agencies ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 0.1 g/ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - gamunex is indicated as replacement therapy of primary immunodeficiency (pi) states in which severe impaiment of antibody forming capacity has been shown, such as congential agammaglobulinemia, common variable immunodeficiency, x-limked immunodeficiency with hyper igm, wiskott- aldrich syndrom, and severed combined immunodeficiencies. gamunex is also indicated in idiopathic thrombocytopenia purpura (itp) to raise platelet counts to prevent bleeding or to allow a patient with itp to undergo surgery.treatment of chronic inflammatory demyelinating polyneuropathy (cidp).

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - auvi-q® is 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. auvi-q is 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. auvi-q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care. none. 8.1 pregnancy teratogenic effects: pregnancy category c. there are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women. epinephrine was teratogenic in rabbits, mice and hamsters. epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both). epinephrine has been shown to have teratogenic effects when administered subcutaneously in rabbits at approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal dose of 1.2 mg/kg/day for two to three days), in mice at approximately 7 times the maximum daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal subcutaneous dose of 1 mg/kg/day for 10 days), and in hamsters at approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days). these effects were not seen in mice at approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). 8.3 nursing mothers it is not known whether epinephrine is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when auvi-q is administered to a nursing woman. 8.4 pediatric use auvi-q may be administered to pediatric patients at a dosage appropriate to body weight [see dosage and administration ( 22)]. 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 auvi-q are fixed, consider using other forms of injectable epinephrine if doses lower than 0.1 mg are deemed necessary. 8.5 geriatric use clinical studies of auvi-q did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. epinephrine 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-(5.5), overdosage ( 10)]. auvi-q® (epinephrine injection) auto-injector for allergic emergencies (anaphylaxis) read this patient information leaflet before you have to use auvi-q and each time you get a refill. there may be new information. you should know how to use auvi-q 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 auvi-q? always carry auvi-q with you because you may not know when a life-threatening allergic reaction (anaphylactic reaction) may happen. talk to your doctor if you need additional units to keep at work, school, etc. an anaphylactic reaction is a life-threatening allergic reaction that can happen within minutes and can be caused by stinging and biting insects (bees, wasps, hornets, and mosquitoes), allergy shots, foods, medicines, exercise, or other unknown causes. follow your healthcare provider’s instructions on when to use auvi-q if you have the symptoms of an anaphylactic reaction, which may include the symptoms listed below: 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 dizziness or fainting tell your family members and others where you keep auvi-q and how to use it before you need it. you may be unable to speak in an allergic emergency. get medical attention immediately after using auvi-q. if you have a serious allergic reaction, you may need more medicine. what is auvi-q? auvi-q is a prescription medicine used to treat life-threatening allergic reactions including anaphylaxis in people who are at risk for or have a history of serious allergic reactions. auvi-q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. you should get emergency medical help right away after using auvi-q. it is not known if auvi-q is safe and effective in children who weigh less than 16.5 pounds (7.5 kg). what should i tell my healthcare provider before using auvi-q? before you use auvi-q, tell your healthcare provider if you: have heart problems or high blood pressure have diabetes have thyroid problems have history of depression have parkinson’s disease have any other medical conditions are pregnant or plan to become pregnant. it is not known if auvi-q will harm your unborn baby. are breastfeeding or plan to breastfeed. it is not known if auvi-q passes into your breast milk. tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. auvi-q and other medicines may affect each other, causing side effects. auvi-q may affect the way other medicines work, and other medicines may affect how auvi-q works. know the medicines you take. keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. how should i use auvi-q? each auvi-q contains only 1 dose of medicine. auvi-q should only be injected into the muscle of your outer thigh. it can be injected through your clothing, if needed. read the instructions for use at the end of this patient information leaflet for information about the right way to use auvi-q. use auvi-q exactly as your healthcare provider tells you to use it. a trainer for auvi-q with a separate trainer instructions for use leaflet is included with auvi-q. additional training resources are available at www.auvi-q.com. practice with the trainer for auvi-q before an allergic emergency happens to make sure you are able to safely use the real auvi-q in an emergency. the trainer for auvi-q does not contain a needle or medicine and can be reused to practice your injection. what are the possible side effects of auvi-q? auvi-q may cause serious side effects. auvi-q should only be injected into your outer thigh. do not inject auvi-q into your: veins buttocks fingers, toes, hands or feet if you accidentally inject auvi-q into any other part of your body, go to the nearest hospital emergency room right away. tell the healthcare provider where on your body you received the accidental injection. rarely, patients who use auvi-q 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 if you inject a young child or infant with auvi-q, hold their leg firmly in place before and during the injection to prevent injuries. ask your healthcare provider to show you how to properly hold the leg of a young child or infant during an injection. if you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use auvi-q. talk to your healthcare provider about all your medical conditions. common side effects of auvi-q include: fast, irregular, or ‘pounding’ heart beat sweating shakiness headache paleness feelings of over excitement, nervousness, or anxiety weakness dizziness nausea and vomiting breathing problems tell your healthcare provider if you have any side effect that bothers you or that does not go away. these are not all of the possible side effects of auvi-q. 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 auvi-q? store auvi-q at 68° to 77°f (20° to 25°c). do not expose to extreme heat or cold. for example, do not store in your vehicle’s glove box. do not store auvi-q in the refrigerator or freeze. examine contents in the viewing window periodically. solution should be clear. if the solution is discolored (pinkish color or darker than slightly yellow), cloudy or contains solid particles, replace the unit. your auvi-q has an expiration date. replace it before the expiration date. keep auvi-q in the outer case it comes in to protect it from light. keep auvi-q and all medicines out of the reach of children. general information about the safe and effective use of auvi-q: medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use auvi-q for a condition for which it was not prescribed. do not give auvi-q to other people, even if they have an allergic reaction or the same symptoms that you have. it may harm them. this patient information leaflet summarizes the most important information about auvi-q. if you would like more information, talk to your healthcare provider. you can ask your pharmacist or healthcare provider for information about auvi-q that is written for health professionals. for more information and video instructions on the use of auvi-q, go to www.auvi-q.com or call 1-844-828-8472. what are the ingredients in auvi-q? active ingredient: epinephrine. inactive ingredients: sodium chloride, sodium bisulfite, hydrochloric acid, and water. auvi-q does not contain latex. instructions for use read these instructions for use carefully before you need to use your auvi-q. before you use auvi-q, make sure your healthcare provider shows you the right way to use it. if you have any questions, ask your healthcare provider. if you are administering auvi-q to a young child or infant, hold the leg firmly in place and limit movement prior to and while administering an injection. automated voice instructions auvi-q contains an electronic voice instruction system to help guide you through each step of your injection. if the voice instructions do not work for any reason, use auvi-q as instructed in these instructions for use. it will still work during an allergic reaction emergency. how to use your auvi-q figure a. 1. pull auvi-q up from the outer case. see figure b. do not go to step 2 until you are ready to use auvi-q. if you are not ready to use auvi-q, put it back in the outer case. figure b. 2. pull red safety guard down and off of auvi-q. see figure c. to reduce the chance of an accidental injection, do not touch the black base of the auto-injector, which is where the needle comes out. if an accidental injection happens, get medical help right away. note: the red safety guard is made to fit tight. pull firmly to remove. figure c. 3. place black end of auvi-q against the middle of the outer thigh (through clothing, if needed), then push firmly until you hear a click and hiss sound, and hold in place for 2 seconds. see figure d. only inject into the middle of the outer thigh. do not inject into any other part of the body. if you are administering auvi-q to a young child or infant, hold the leg firmly in place while administering an injection see figure e. figure d. (for auvi-q 0.3 mg and auvi-q 0.15 mg) figure e. (for auvi-q 0.1 mg) note: auvi-q makes a distinct sound (click and hiss) when you push it against your outer thigh. this is normal and indicates auvi-q is working correctly. do not pull auvi-q away from your leg when you hear the click and hiss sound. the needle automatically retracts after the injection is complete, so the needle will not be visible after the injection. auvi-q includes a 2-second countdown after it is activated, then the voice instruction will indicate the injection is complete, and to seek emergency medical attention, auvi-q will beep, and the lights will blink red. 4. get emergency medical help right away. replace the outer case and talk to your healthcare provider about the right way to throw away your auvi-q. ask your healthcare provider for an auvi-q prescription refill. after the use of auvi-q: the black base will lock into place. the voice instruction system will say “seek emergency medical attention”, say “this auvi-q has been used…”, and the lights will blink red. the red safety guard cannot be replaced. the viewing window will no longer be clear. it is normal for some medicine to remain in your auvi-q after you have received your dose of medicine. talk to your healthcare provider about the right way to throw away your auvi-q. auvi-q is a single-use auto-injector and cannot be reused. until you throw away your used auvi-q, the electronic voice instruction system will remind you that it has been used when the outer case is removed. if you will be administering auvi-q to a young child or infant, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose. this patient information has been approved by the u.s. food and drug administration. rev nov 2017 manufactured for: kaleo, inc. richmond, va 23219 usa this product may be covered by one or more u.s. patents or pending patent applications. see www.kaleopharma.com/pat for details. *for california only: this product uses batteries containing perchlorate material – special handling may apply. see www.dtsc.ca.gov/hazardouswaste/perchlorate important: the trainer for auvi-q does not contain a needle or medicine. in case of an allergic emergency, use the real auvi-q and not the gray trainer. always carry your real auvi-q with you in case of an allergic emergency. important information about the trainer for auvi-q: inside your trainer for auvi-q are: batteries a speaker that will make a beeping sound and that produces electronic voice instructions red and green blinking lights the trainer for auvi-q batteries are made to last long enough for you to practice 1 time each day for 2 years. if your trainer for auvi-q does not work properly call your healthcare provider for a new trainer. storage: store the trainer for auvi-q at room temperature; the trainer for auvi-q should not be used at temperatures less than 50°f (10°c) or greater than 104°f (40°c). store the trainer for auvi-q in its outer case. keep the trainer for auvi-q away from dirt, chemicals, and water. disposal: the trainer for auvi-q contains electronics and lithium coin cell batteries, and should be disposed of in the correct manner. follow your state and local environmental regulations for disposal. for california only: this product uses batteries containing perchlorate material - special handling may apply. see www.dtsc.ca.gov/hazardouswaste/perchlorate manufactured for: kaleo, inc. richmond, va 23219 usa this product may be covered by one or more u.s. patents or pending patent applications. see www.kaleopharma.com/pat for details. rev nov 2017

Σιγκαπούρη - Αγγλικά - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - dupilumab - injection, solution - dupilumab 300 mg/2ml

Σιγκαπούρη - Αγγλικά - HSA (Health Sciences Authority)

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

Ηνωμένες Πολιτείες - Αγγλικά - 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

Ισραήλ - Αγγλικά - Ministry of Health

taro pharmaceutical industries ltd - selenium sulfide - suspension - selenium sulfide 25 mg/ml - selenium sulfide - selenium sulfide - for the treatment of dandruff, seborrheic dermatitis of the scalp and tinea versicolor.

Ισραήλ - Αγγλικά - Ministry of Health

a.m.i. medical technologies limited, israel - amorolfine as hydrochloride - lacquer - amorolfine as hydrochloride 5 %w/v - amorolfine - amorolfine - topical treatment of onycomycosis caused by dermatophytes, yeast and moulds.

Ισραήλ - Αγγλικά - Ministry of Health

rafa laboratories ltd - minocycline as hydrochloride - capsules - minocycline as hydrochloride 50 mg - minocycline - minocycline - treatment of infections caused by minocycline-sensitive micro-organisms including acne, gonorrhea and prophylaxis of asymptomatic meningococcal carrier.

Ισραήλ - Αγγλικά - Ministry of Health

rafa laboratories ltd - minocycline as hydrochloride - capsules - minocycline as hydrochloride 100 mg - minocycline - minocycline - treatment of infections caused by minocycline-sensitive micro-organisms including acne, gonorrhea and prophylaxis of asymptomatic meningococcal carrie.