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hikma canada limited - epinephrine - solution - 1mg - epinephrine 1mg - alpha-and beta-adrenergic agonists

United States - English - 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. - 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 - 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. - 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) 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 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 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 1-724-465-8762 put the blue safety release back on the trainer.

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine epinephrine’s cardiac effects may be of use in the treatment and prophylaxis of cardiac arrest due to various causes in the absence of ventricular fibrillation and attacks of transitory atrioventricular (av) heart block with syncopal seizures (stokes-adams syndrome), but it is not used in cardiac failure or in hemorrhagic, traumatic or in cardiogenic shock. epinephrine may be used to stimulate the heart in syncope due to complete heart block or carotid sinus hypersensitivity. epinephrine is also used for resuscitation in cardiac arrest following anesthetic accidents. in cardiopulmonary resuscitation, intracardiac puncture and intramyocardial injection of epinephrine may be effective when external cardiac compression and attempts to restore the circulation by electrical defibillation or use of a pacemaker fail. epinephrine is seldom used as a vasopressor except in the treatment of anaphylactic shock and under certain conditions in insulin shock. epinephrine should not be used in the presence of cardiac dilatation or coronary insufficiency. epinephrine is contraindicated in shock during general anesthesia with halogenated hydrocarbons or cyclopropane, and in individuals with organic brain damage. epinephrine is also contraindicated with local anesthesia of certain areas; e.g., fingers, toes, because of the danger of vasoconstriction producing sloughing of tissue; also contraindicated in labor because it may delay the second stage. epinephrine should not be used in those cases where vasopressor drugs may be contraindicated, e.g., in thyrotoxicosis, diabetes, in obstetrics when maternal blood pressure is in excess of 130/80, and in hypertension and other cardiovascular disorders.

United States - English - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine epinephrine’s cardiac effects may be of use in the treatment and prophylaxis of cardiac arrest due to various causes in the absence of ventricular fibrillation and attacks of transitory atrioventricular (av) heart block with syncopal seizures (stokes-adams syndrome), but it is not used in cardiac failure or in hemorrhagic, traumatic or in cardiogenic shock. epinephrine may be used to stimulate the heart in syncope due to complete heart block or carotid sinus hypersensitivity. epinephrine is also used for resuscitation in cardiac arrest following anesthetic accidents. in cardiopulmonary resuscitation, intracardiac puncture and intramyocardial injection of epinephrine may be effective when external cardiac compression and attempts to restore the circulation by electrical defibillation or use of a pacemaker fail. epinephrine is seldom used as a vasopressor except in the treatment of anaphylactic shock and under certain conditions in insulin shock. epinephrine should not be used in the presence of car

United States - English - 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-

United States - English - NLM (National Library of Medicine)

bpi labs llc - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine epinephrine’s cardiac effects may be of use in the treatment and prophylaxis of cardiac arrest due to various causes in the absence of ventricular fibrillation and attacks of transitory atrioventricular (av) heart block with syncopal seizures (stokes-adams syndrome), but it is not used in cardiac failure or in hemorrhagic, traumatic or in cardiogenic shock. epinephrine may be used to stimulate the heart in syncope due to complete heart block or carotid sinus hypersensitivity. epinephrine is also used for resuscitation in cardiac arrest following anesthetic accidents. in cardiopulmonary resuscitation, intracardiac puncture and intramyocardial injection of epinephrine may be effective when external cardiac compression and attempts to restore the circulation by electrical defibillation or use of a pacemaker fail. epinephrine is seldom used as a vasopressor except in the treatment of anaphylactic shock and under certain conditions in insulin shock. epinephrine should not be used in the presence of car

United States - English - 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 .

Canada - English - Health Canada

searchlight pharma inc - epinephrine (epinephrine hydrochloride) - solution - 1mg - epinephrine (epinephrine hydrochloride) 1mg - vasoconstrictors

Malta - English - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - norepinephrine - concentrate for solution for infusion - norepinephrine 2 mg/ml - cardiac therapy

Malta - English - Medicines Authority

mercury pharma international limited 4045 kingswood road, city west business park, co, dublin, ireland - epinephrine - solution for injection - epinephrine 1 mg/ml - cardiac therapy