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

hf acquisition co llc, dba healthfirst - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine injection, usp is indicated for intravenous injection in (1) treatment of acute hypersensitivity (anaphylactoid reactions to drugs, animal serums and other allergens), (2) treatment of acute asthmatic attacks to relieve bronchospasm not controlled by inhalation or subcutaneous administration of other solutions of the drug and (3) treatment and prophylaxis of cardiac arrest and attacks of transitory atrioventricular (a-v) heart block with syncopal seizures (stokes-adams syndrome). in acute attacks of ventricular standstill, physical measures should be applied first. when external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a pacemaker fail, intracardiac puncture and intramyocardial injection of epinephrine may be effective. epinephrine is contraindicated in patients with known hypersensitivity to sympathomimetic amines, in patients with angle closure glaucoma, and patients in shock (nonanaphylactic). it should not be used in patients anesthetiz

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)

henry schein, inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine injection, usp is indicated for intravenous injection in (1) treatment of acute hypersensitivity (anaphylactoid reactions to drugs, animal serums and other allergens), (2) treatment of acute asthmatic attacks to relieve bronchospasm not controlled by inhalation or subcutaneous administration of other solutions of the drug and (3) treatment and prophylaxis of cardiac arrest and attacks of transitory atrioventricular (a-v) heart block with syncopal seizures (stokes-adams syndrome). in acute attacks of ventricular standstill, physical measures should be applied first. when external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a pacemaker fail, intracardiac puncture and intramyocardial injection of epinephrine may be effective. epinephrine is contraindicated in patients with known hypersensitivity to sympathomimetic amines, in patients with angle closure glaucoma, and patients in shock (nonanaphylactic). it should not be used in patients anesthetiz

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

generic medical partners inc - norepinephrine (norepinephrine bitartrate) - solution - 1mg - norepinephrine (norepinephrine bitartrate) 1mg - alpha-and beta-adrenergic agonists

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

baxter healthcare corporation - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - for blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). as an adjunct in the treatment of cardiac arrest and profound hypotension. norepinephrine bitartrate injection, usp should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. if norepinephrine bitartrate injection, usp is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite "normal" blood pressure, tissue hypoxia, and lactate acidosis. norepinephrine bitartrate injection, usp should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction) unless, in the opinion of the attending physician, the administration of norepinephrine bitartrate injection, usp is necessary as a life-saving procedure. cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. hence, the use of norepinephrine bitartrate injection, usp during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. the same type of cardiac arrhythmias may result from the use of norepinephrine bitartrate injection, usp in patients with profound hypoxia or hypercarbia.

Canada - English - Health Canada

baxter corporation - norepinephrine (norepinephrine bitartrate) - solution - 0.016mg - norepinephrine (norepinephrine bitartrate) 0.016mg - alpha-and beta-adrenergic agonists

Canada - English - Health Canada

baxter corporation - norepinephrine (norepinephrine bitartrate) - solution - 0.032mg - norepinephrine (norepinephrine bitartrate) 0.032mg - alpha-and beta-adrenergic agonists

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

long grove pharmaceuticals, llc - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine in sodium chloride injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated (see clinical considerations) . in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data) . increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m2 basis for four days during organogenesis (see data) . the estimated background risk for major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus. data animal data a study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2-4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. decreases in fetal oxygenation, urine and lung liquid flow were also observed. norepinephrine administration to pregnant rats on gestation day 16 or 17 resulted in cataract production in rat fetuses. in hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from gestation day 7-10). risk summary there are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine. safety and effectiveness in pediatric patients have not been established. clinical studies of norepinephrine in sodium chloride injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. avoid administration of norepinephrine in sodium chloride injection into the veins in the leg in elderly patients [see warnings and precautions (5.1)] .

Canada - English - Health Canada

laboratoire aguettant - epinephrine (epinephrine bitartrate) - solution - 1mg - epinephrine (epinephrine bitartrate) 1mg - alpha-and beta-adrenergic agonists