From Bayer’s press release: “Innovating in order to provide two reconstitution systems, Vial Adapter and BIO-SET®, is a great example of our commitment to delivering options that meet the needs of the entire hemophilia A community,” said Pamela Cyrus, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.
Both Kogenate® FS with BIO-SET® and Kogenate® FS with Vial Adapter are available in Grab and Go packaging, which includes:
· A prefilled diluent syringe
· The Terumo® SURFLO® Winged Infusion Set
· Alcohol swabs, a cotton pad and a latex-free bandage
· Exclusive anti-counterfeiting and tamper-evident features
· Alcohol swabs, a cotton pad and a latex-free bandage
· Exclusive anti-counterfeiting and tamper-evident features
Kogenate® FS, antihemophilic factor (recombinant) is indicated for:
· Control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A
· Peri-operative management in adults and children with hemophilia A
· Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage
Kogenate® FS is not indicated for the treatment of von Willebrand disease.
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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
For important risk and use information, please see the full prescribing information at https://www.kogenatefs.com/webapp/prescribing-information.jsp
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