sábado, 17 de junio de 2017

FDA approves new epinephrine injection for emergency treatment of allergic reactions- Drug Information Update

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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The FDA approved Symjepi (epinephrine injection) 0.3 mg pre-filled syringe for the emergency treatment of allergic reactions, including anaphylaxis. The product delivers 0.3 mg of epinephrine and is intended for patients who weigh 30 kg (approximately 66 pounds) or more.
This is a new drug alternative to EpiPen. It is not an alternative for EpiPen Jr, which is indicated for patients who weigh between 15 and 30 Kg (approximately 33 and 66 pounds). 

Symjepi is intended for immediate administration as emergency supportive therapy and is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical care. More than two sequential doses of epinephrine should only be administered under direct medical supervision. Symjepi pre-filled syringes  are available as a single pack containing a single pre-filled syringe, and as a two-pack (containing 2 pre-filled syringes). 

The FDA granted approval of Symjepi to Adamis Pharmaceuticals Corporation.

For more information, please visit: Symjepi.

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