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INDICATIONS & USAGE

Kogenate® FS, antihemophilic factor (recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative 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

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® 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.

© 2010 Bayer HealthCare Pharmaceuticals Inc. All rights reserved.
BAYER, the Bayer Cross, and KOGENATE are registered trademarks of Bayer.
BIO-SET is a trademark of Biodome SAS.

Kogenate FS Antihemophilic Factor (Recombinant) with BIO-SET Needleless Reconstitution System