Epinephrine by is a Prescription medication manufactured, distributed, or labeled by Medical Purchasing Solutions, LLC. Drug facts, warnings, and ingredients follow.
Epinephrine injection, USP auto-injector contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. ( 1)
Inject intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Each device is a single-use injection . ( 2)
None ( 4)
Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties. ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Mylan Specialty, L.P. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2017
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)] .
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.
Epinephrine was teratogenic in rabbits, mice and hamsters. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both).
Epinephrine has been shown to have teratogenic effects when administered subcutaneously in rabbits at approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a maternal dose of 1.2 mg/kg/day for two to three days), in mice at approximately 7 times the maximum daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a maternal subcutaneous dose of 1 mg/kg/day for 10 days), and in hamsters at approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days).
These effects were not seen in mice at approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m 2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).
It is not known whether epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when epinephrine injection, USP auto-injector is administered to a nursing woman.
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)].
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 and to be an oxidative mutagen in a WP2 bacterial reverse mutation assay.
Epinephrine was positive in the DNA Repair test with B. subtilis (REC) assay, but was not mutagenic in the Salmonella bacterial reverse mutation assay.
The potential for epinephrine to impair fertility has not been evaluated.
This should not prevent the use of epinephrine under the conditions noted under Indications and Usage (1).
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 © 2017 Meridian Medical Technologies. All rights reserved.
Revised: 2/2017
MS:EPIG:R2
0001997
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
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 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 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: 2/2017
MS:PIL:EPIG:R2
0001998
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
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: 2/2017
MS:EPITG:R2
0001999
NDC: 71872-7134-1
Rx only
For Allergic Emergencies (Anaphylaxis)
Epinephrine Injection, USP
1 - Auto-Injectors 0.15 mg
Authorized generic for
EpiPen Jr
® Auto-Injector
For more information about your Epinephrine Injection, USP
Auto-Injectors visit
MyGenericEAI.com
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.
Each
Epinephrine Injection, USP Auto-Injector delivers one 0.15 mg
intramuscular dose of epinephrine from epinephrine injection, USP
0.15 mg/0.3 mL.
Discard unit after use.
Replace if discolored. Store at 68° to 77°F
(20° to 25°C). Do not refrigerate.
Protect from light.
EPINEPHRINE
epinephrine injection |
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Labeler - Medical Purchasing Solutions, LLC (601458529) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Medical Purchasing Solutions, LLC | 601458529 | repack(71872-7134) |