INDICATION:

Twinject (epinephrine injection, USP 1:1000) is indicated in the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging insects (e.g. order Hymenoptera, which includes 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 anaphylaxis to unknown substancess (idiopathic anaphylaxis) or exercise-induced anaphylaxis.

IMPORTANT SAFETY INFORMATION ABOUT TWINJECT:

Twinject should only be injected into the anterolateral aspect of the thigh. Accidental injection into the hands or feet may result in loss of blood flow to the affected area and should be avoided. DO NOT INJECT INTO BUTTOCK. DO NOT INJECT INTRAVENOUSLY.

Epinephrine should be administered with caution to patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute life-threatening situation.

Adverse reactions to epinephrine may include flushing; apprehension; syncope; tachycardia; thready pulse with a fall in blood pressure; convulsions; respiratory difficulties; vomiting, diarrhea or cramps; pruritus; or angioderma. Twinject is designed as an emergency supportive therapy only and is not a replacement or substitute for immediate medical care.

Since the doses of epinephrine delivered from Twinject are fixed, the physician should consider other forms of injectable epinephrine if doses lower than those available from Twinject are felt to be necessary (e.g., patients who weigh less than 15 kilograms approximately 33 pounds). IN ALL CASES, THE PHYSICIAN SHOULD INSTRUCT THE PATIENT AND/OR ANY OTHER PERSON WHO MIGHT BE IN A POSITION TO ADMINISTER THE EPINEPHRINE, IN THE PROPER USE OF TWINJECT.

Please see complete prescribing information for more details.

Your doctor can give you more information about Twinject or call 1-888-TWIN-JCT. Ask your doctor if Twinject may be right for you.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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Twinject is a registered trademark of Shionogi Pharma, Inc.
© 2008 Shionogi Pharma, Inc. Atlanta, Georgia. All rights reserved. TWI.07.08.036.03

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