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These highlights do not include all the information needed to use EPINEPHRINE INJECTION, USP AUTO- INJECTOR safely and effectively. See full prescribing information for EPINEPHRINE INJECTION, USP AUTO- INJECTOR. EPINEPHRINE injection, USP Auto-Injector, | Epinephrine [Mylan Specialty L.P.] | BioPortfolio

13:26 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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.

Selection of the appropriate epinephrine injection, USP auto-injector is determined according to patient body weight.

Inject epinephrine injection, USP auto-injector intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed an epinephrine injection, USP auto-injector and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see Warnings and Precautions (5.2) ].

Each epinephrine injection, USP auto-injector contains a single dose of epinephrine for single-use injection. Since the doses of epinephrine delivered from epinephrine injection, USP auto-injector are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. With severe persistent anaphylaxis, repeat injections with an additional epinephrine injection, USP auto-injector may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Warnings and Precautions (5.1) ].

The epinephrine solution in the clear window of the epinephrine injection, USP auto-injector should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light [see How Supplied/Storage and Handling (16.2) ].

None

Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy and are not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Indications and Usage (1), Dosage and Administration (2) and Patient Counseling Information (17) ].

Epinephrine injection, USP auto-injector should only be injected into the anterolateral aspect of the thigh [see Dosage and Administration (2) and Patient Counseling Information (17) ].

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject epinephrine injection, USP auto-injector into the buttock [see Warnings and Precautions (5.2) ]. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.

The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.

Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium metabisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.

The alternatives to using epinephrine in a life-threatening situation may not be satisfactory.

Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer epinephrine injection, USP auto-injector to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used.

Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias [see Drug Interactions (7) and Adverse Reactions (6) ].

Epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. Patients with Parkinson’s disease may notice a temporary worsening of symptoms.

Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below.

Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [see Warnings and Precautions (5.5) ].

Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see Warnings and Precautions (5.5) and Drug Interactions (7) ].

Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see Warnings and Precautions (5.5) ].

Angina may occur in patients with coronary artery disease [see Warnings and Precautions (5.5) ].

Rare cases of stress cardiomyopathy have been reported in patients treated with epinephrine.

Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see Warnings and Precautions (5.2) ].

Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.

Lacerations, bent needles, and embedded needles have been reported when epinephrine injection, USP auto-injector has been injected into the thigh of young children who are uncooperative and kick or move during the injection [see Warning and Precautions (5.2) ].

Injection into the buttock has resulted in cases of gas gangrene [see Warnings and Precautions (5.2) ].

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection, including epinephrine injection, USP auto-injector, in the thigh [see Warnings and Precautions (5.3) ].

Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see Warnings and Precautions (5.5) ].

The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.

The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta- adrenergic blocking drugs, such as propranolol.

The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha- adrenergic blocking drugs, such as phentolamine.

Ergot alkaloids may also reverse the pressor effects of epinephrine.

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 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 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 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 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 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) ]. 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) ].

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.

Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.

Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.

Epinephrine injection, USP auto-injectors, 0.3 mg and 0.15 mg, are auto-injectors and combination products containing drug and device components.

Each epinephrine injection, USP auto-injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution.

Each epinephrine injection, USP auto-injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution.

The epinephrine injection, USP auto-injector contains 2 mL epinephrine solution. Approximately 1.7 mL remains in the auto-injector after activation, but is not available for future use, and should be discarded.

Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.3 mg contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0.

Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.15 mg contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0.

Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure:

Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles.

Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [see Patient Counseling Information (17) ].

Epinephrine acts on both alpha- and beta-adrenergic receptors.

Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension.

Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis.

Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.

When given subcutaneously or intramuscularly, epinephrine has a rapid onset and short duration of action.

Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted.

Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro. Epinephrine was positive in the Salmonella bacterial reverse mutation assay, positive in the mouse lymphoma assay, and negative in the in vivo micronucleus assay. Epinephrine is an oxidative mutagen based on the E. coli WP2 Mutoxitest bacterial reverse mutation assay. This should not prevent the use of epinephrine under the conditions noted under Indications and Usage (1).

The potential for epinephrine to impair reproductive performance has not been evaluated, but epinephrine has been shown to decrease implantation in female rabbits dosed subcutaneously with 1.2 mg/kg/day (40-fold the highest human intramuscular or subcutaneous daily dose) during gestation days 3 to 9.

Epinephrine Injection, USP Auto-Injectors, 0.3 mg (epinephrine injections, USP 0.3 mg/0.3 mL) are available as NDC 49502-102-02, a pack that contains two Epinephrine Injection, USP Auto-Injectors, 0.3 mg (epinephrine injections, USP 0.3 mg/0.3 mL) and one Epinephrine Injection, USP Auto-Injector Trainer device.

Epinephrine Injection, USP Auto-Injectors, 0.15 mg (epinephrine injections, USP 0.15 mg/0.3 mL) are available as NDC 49502-101-02, a pack that contains two Epinephrine Injection, USP Auto-Injectors, 0.15 mg (epinephrine injections, USP 0.15 mg/0.3 mL) and one Epinephrine Injection, USP Auto-Injector Trainer device.

Epinephrine Injection, USP Auto-Injectors also include an S-clip to clip two carrier tubes together.

Rx only

Protect from light. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.

[See FDA-Approved Patient Labeling (Patient Information and Instructions for Use).]

A healthcare provider should review the patient instructions and operation of epinephrine injection, USP auto-injector in detail, with the patient or caregiver.

Epinephrine is essential for the treatment of anaphylaxis. Patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, should be carefully instructed about the circumstances under which epinephrine should be used.

Administration and Training

Instruct patients and/or caregivers in the appropriate use of epinephrine injection, USP auto-injector. Epinephrine injection, USP auto-injector should be injected into the middle of the outer thigh (through clothing, if necessary). Each device is a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of epinephrine injection, USP auto-injectors.

Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection. Lacerations, bent needles, and embedded needles have been reported when epinephrine injection, USP auto-injector has been injected into the thigh of young children who are uncooperative and kick or move during an injection [see Warnings and Precautions (5.2) ].

Complete patient information, including dosage, directions for proper administration and precautions can be found inside each epinephrine injection, USP auto-injector carton. A printed label on the surface of epinephrine injection, USP auto-injector shows instructions for use and a diagram depicting the injection process.

Instruct patients and/or caregivers to use and practice with the Trainer to familiarize themselves with the use of epinephrine injection, USP auto-injector in an allergic emergency. The Trainer may be used multiple times. A Trainer device is provided in epinephrine injection, USP auto-injector cartons.

Adverse Reactions

Epinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These signs and symptoms usually subside rapidly, especially with rest, quiet and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson’s disease may notice a temporary worsening of symptoms [see Warnings and Precautions (5.5) ].

Accidental Injection

Advise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands, or feet, treatment should be directed at vasodilatation if there is such an accidental injection to these areas [see Warnings and Precautions (5.2) ].

Serious Infections at the Injection Site

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [see Warnings and Precautions (5.3) ].

Storage and Handling

Instruct patients to inspect the epinephrine solution visually through the clear window of the auto-injector periodically. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. The carrier tube is not waterproof. Instruct patients that epinephrine injection, USP auto-injector must be used or properly disposed once the blue safety release is removed or after use [see Storage and Handling (16.2) ].

Complete patient information, including dosage, directions for proper administration and precautions can be found inside each epinephrine injection, USP auto-injector carton.

Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company

Copyright © 2018 Meridian Medical Technologies.  All rights reserved.

Revised: 8/2018MS:EPIG:R30002030

Epinephrine Injection, USP Auto-Injector 0.3 mgone dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL

Epinephrine Injection, USP Auto-Injector 0.15 mgone 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)

Patient Information

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. You, your parent, caregiver, or others who may be in a position to administer 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 the Epinephrine Injection, USP Auto-Injector?

What are epinephrine injection, USP auto-injectors?

What should I tell my healthcare provider before using the epinephrine injection, USP auto-injector?

Before you use epinephrine injection, USP auto-injector, tell your healthcare provider about all your medical conditions, but especially if you:

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 of all 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, and other medicines may affect how epinephrine injection, USP auto-injector works.

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, 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 epinephrine injection, USP auto-injectors?

What are the possible side effects of epinephrine injection, USP auto-injectors?

Epinephrine injection, USP auto-injectors may cause serious side effects.

Common side effects of epinephrine injection, USP auto-injector include:

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 healthcare provider 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?

Keep epinephrine injection, USP auto-injectors and all medicines out of the reach of children.

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 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.

For more information and video instructions on the use of epinephrine injection, USP auto-injectors, go to MyGenericEAI.com or call 1-800-395-3376.

What are the ingredients in epinephrine injection, USP auto-injectors?

Important Information

Instructions for Use

Epinephrine Injection, USP Auto-Injector 0.3 mgone dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL

Epinephrine Injection, USP Auto-Injector 0.15 mgone dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL

For allergic emergencies (anaphylaxis)

Read these Instructions for Use carefully before you use epinephrine injection, USP auto-injector. Before you need to use your epinephrine injection, USP 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, USP auto-injector should also understand how to use it as well. If you have any questions, ask your healthcare provider.

Your epinephrine injection, USP auto-injectors

A dose of epinephrine injection, USP auto-injector requires 3 simple steps: Prepare, Administer and Get emergency medical help

If you are administering epinephrine injection, USP auto-injector to a young child, hold the leg firmly in place while administering an injection.

You may need further medical attention. You may need to use a second epinephrine injection, USP auto-injector if symptoms continue or recur.

Note:

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company

Copyright © 2017 Meridian Medical Technologies.  All rights reserved.

Revised: 2/2017MS:PIL:EPIG:R20001998

Epinephrine Injection, USP Auto-Injector 0.3 mgone dose of 0.3 mg epinephrine, USP 0.3 mg/0.3 mL

Epinephrine Injection, USP Auto-Injector 0.15 mgone dose of 0.15 mg epinephrine, USP 0.15 mg/0.3 mL

MyGenericEAI.com

Register your epinephrine injection, USP auto-injector at MyGenericEAI.com and find out more about:

Register up to 6 epinephrine injection, USP auto-injectors and receive automatic Refill Reminder Alerts.

For more information about epinephrine injection, USP auto-injectors and proper use of the product, call Mylan at 1-877-446-3679 or visit MyGenericEAI.com.

Epinephrine Injection, USP Auto-Injector Trainer Instructions for Use

Epinephrine Injection, USP Auto-Injector Trainer Instructions for Use

In an emergency: Do not use the grey Trainer. Use your real yellow epinephrine injection, USP auto-injector, 0.3 mg or green epinephrine injection, USP auto-injector, 0.15 mg.

Important Information

The Epinephrine Injection, USP Auto-Injector Trainer

Familiarize yourself with this grey Trainer. Practice until you are comfortable using it.

Your grey colored Trainer:

Practice Instructions

Note: With the real yellow epinephrine injection, USP auto-injector, 0.3 mg or green epinephrine injection, USP auto-injector, 0.15 mg, 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, USP auto-injector, 0.3 mg or green epinephrine injection, USP auto-injector, 0.15 mg and not the grey Trainer.

Follow instructions above. Repeat as often as needed until you are able to self-inject quickly and correctly.

Reread:

Train others who could help you in an emergency:

For more information about Epinephrine Injection, USP Auto-Injectors and the proper use of the products, go to MyGenericEAI.com.

Caution:

Important differences between the Trainer and your real yellow epinephrine injection, USP auto-injector, 0.3 mg or green epinephrine injection, USP auto-injector, 0.15 mg

This Trainer Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for Mylan Specialty L.P., Morgantown, WV 26505, U.S.A. by Meridian Medical Technologies, Inc., Columbia, MD 21046, U.S.A., a Pfizer company

Copyright © 2017 Meridian Medical Technologies.  All rights reserved.

Revised: 2/2017MS:EPITG:R20001999

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 medical help right away.
Remove the epinephrine injection, USP auto-injector from the clear carrier tube.
 
Flip open the yellow cap of your epinephrine injection, USP auto-injector, 0.3 mg or the green cap of your epinephrine injection, USP auto-injector, 0.15 mg carrier tube.
Tip and slide the auto-injector out of the carrier tube.
Grasp the auto-injector in your fist with the orange tip (needle end) pointing downward.  
With your other hand, remove the blue safety release by pulling straight up without bending or twisting it.
Note:
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.
Hold firmly in place for 3 seconds (count slowly 1, 2, 3). The injection is now complete.
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.
Massage the injection area for 10 seconds.
Grasp the grey Trainer in your fist with the orange tip pointing downward. With your other hand, remove blue safety release by pulling straight up without bending or twisting it. Removing the blue safety release unlocks the Trainer. If practicing with a young child, hold the leg firmly in place while using the epinephrine injection, USP auto-injector Trainer. Ask your healthcare provider to show you how to properly hold the leg to practice so that you will be prepared before an allergic emergency happens.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 medical help right away The actual auto-injector is made to work through clothing Do not inject into any other part of the bodyPut the blue safety release back on the Trainer Place the orange tip on a hard surface Squeeze the sides of the orange tip and push down on the Trainer with the other hand
1 Prepare the Trainer for Simulated Injection
2 Administer the Trainer Simulation
3 To reset the Trainer
TRAINER (Grey) Epinephrine Injection, USP Auto-Injector, 0.3 mg (Yellow) Epinephrine Injection, USP Auto-Injector , 0.15 mg (Green)
Contains medication? NO YES YES
Has needle? NO YES YES
Comes in Carrier Tube? NO YES YES
Color of Label? Grey Yellow Green
Has expiration date? NO YES YES
Can be reused? YES NO (use only once) NO (use only once)
Okay to remove and replace safety release? YES NO (remove just once before use) NO (remove just once before use)
Pressure needed to hold against thigh? Moderate Strong Strong

NDC 49502-102-02 Rx only

For Allergic Emergencies (Anaphylaxis)

Epinephrine Injection, USP Auto-Injectors 0.3 mg

Each carton contains:

Authorized generic for EpiPen Auto-Injector

For more information about your Epinephrine Injection, USPAuto-Injectors visit MyGenericEAI.com

See enclosed Patient Information Leaflet for complete instructions for use.

Note: The needle comes out of the orange tip. Never put your thumb, fingers or hand over the orange tip.

Never put thumb, fingers or hand over orange tip.Do not remove blue safety release until ready to use.

Contains 2 Epinephrine Injection, USP Auto-Injectors and 1 Trainer.Each Epinephrine Injection, USP Auto-Injector delivers one 0.3 mgintramuscular dose of epinephrine from epinephrine injection, USP0.3 mg/0.3 mL.

Discard unit after use. The Trainer contains no medicine and no needle.Read enclosed patient package insert carefully before using.

Replace if discolored. Store at 68° to 77°F (20° to 25°C). Do not refrigerate. Protect from light.

Manufactured for Mylan Specialty L.P., Morgantown, WV 26505 USAby Meridian Medical Technologies, Inc.,Columbia, MD 21046, USA, a Pfizer company.

Copyright© 2017 Meridian Medical Technologies. All rights reserved.

0002000MS:10202:2C:R3

NDC 49502-101-02 Rx only

For Allergic Emergencies (Anaphylaxis)

Epinephrine Injection, USP Auto-Injectors 0.15 mg

Each carton contains:

Authorized generic for EpiPen Jr Auto-Injector

For more information about your Epinephrine Injection, USPAuto-Injectors visit MyGenericEAI.com

See enclosed Patient Information Leaflet for complete instructions for use.

Note: The needle comes out of the orange tip. Never put your thumb, fingers or hand over the orange tip.

Never put thumb, fingers or hand over orange tip.Do not remove blue safety release until ready to use.

Contains 2 Epinephrine Injection, USP Auto-Injectors and 1 Trainer.Each Epinephrine Injection, USP Auto-Injector delivers one 0.15 mgintramuscular dose of epinephrine from epinephrine injection, USP0.15 mg/0.3 mL.

Discard unit after use. The Trainer contains no medicine and no needle.Read enclosed patient package insert carefully before using.

Replace if discolored. Store at 68° to 77°F (20° to 25°C). Do not refrigerate. Protect from light.

Manufactured for Mylan Specialty L.P., Morgantown, WV 26505 USAby Meridian Medical Technologies, Inc.,Columbia, MD 21046, USA, a Pfizer company.

Copyright© 2017 Meridian Medical Technologies. All rights reserved.

0002001MS:10102:2C:R3

Manufacturer

Mylan Specialty L.P.

Active Ingredients

Source

Clinical Trials [222 Associated Clinical Trials listed on BioPortfolio]

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4

Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiova...

Dose Response of Epinephrine

Epinephrine is the principal physiologic defense against hypoglycemia in type 1 and longer duration type 2 DM. Despite this, it is unknown how epinephrine regulates in-vivo endothelial fun...

Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 w...

Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest

Recent studies have suggested that arginine-vasopressin could be more effective in the treatment of cardiac arrests. The last published study did not outline obvious improvements in the pr...

The Effects of Epinephrine in Endotoxemia in Normal Volunteers

Epinephrine (adrenaline) is a substance produced by the body (in the adrenal gland) in response to stress such as infection or injury. Endotoxin is a man- made substance, which causes the ...

PubMed Articles [81 Associated PubMed Articles listed on BioPortfolio]

Efficacy of low-dose nebulized epinephrine as treatment for croup: A randomized, placebo-controlled, double-blind trial.

Croup treatment usually involves a single dose of systemic dexamethasone combined with nebulized epinephrine. However, the optimal dose of l-epinephrine remains unclear. We examined whether a low dose...

Optimal Time Delay of Epinephrine in One-per-mil Solution to Visualize Operation Field.

This study aimed to find out the optimal time delay of epinephrine in one-per-mil tumescent solution containing 1:1,000,000 epinephrine and 0.2% lidocaine to achieve optimal visualization in hand surg...

Association of Fatality Risk With Value-Based Drug Pricing of Epinephrine Autoinjectors for Children With Peanut Allergy: A Cost-effectiveness Analysis.

The high cost of self-injectable epinephrine autoinjectors may represent a barrier to community anaphylaxis management. Value-based pricing can provide a benchmark for rational epinephrine autoinjecto...

Level of knowledge among pharmacists regarding anaphylaxis and the use of epinephrine autoinjectors.

Epinephrine autoinjectors for intramuscular administration are the treatment of choice for self-medicating severe allergic reactions. Data from the anaphylaxis registry shows that patients rarely use ...

Bioavailability of endotracheal epinephrine in an ovine model of neonatal resuscitation.

Distressed infants in the delivery room and those that have completed postnatal transition are both resuscitated according to established neonatal resuscitation guidelines, often with endotracheal (ET...

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Allergies
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...


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