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FDA Approves New 3000 IU Vial Size for Kogenate(R) FS, antihemophilic factor (recombinant)
Date:8/7/2009

is part of Bayer's ongoing efforts to introduce enhancements for the benefit of the people who are treated with Kogenate(R) FS," said Paul Bedard, Vice President and General Manager, Hematology, Bayer HealthCare Pharmaceuticals.

For additional information on Kogenate(R) FS, the 3000 IU vial size and the Kogenate FS Free Trial Program, please visit www.kogenatefs.com/3000IU.

INDICATIONS

Kogenate(R) FS, antihemophilic factor (recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and perioperative management in adults and children (0-16 years) with hemophilia A. Kogenate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.

IMPORTANT SAFETY INFORMATION ABOUT KOGENATE(R) FS

The most serious adverse reactions are systemic hypersensitivity reactions and the development of high titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.

Kogenate(R) FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.

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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SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2009 PR Newswire.
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