If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Kogenate (Antihemophilic Factor) with Bio-Set Approved by European Union RESEARCH TRIANGLE PARK, NC -- October 15, 2004 -- Bayer Biological Products (BP) announced today regulatory approval for Kogenate® Bayer (Antihemophilic Factor [Recombinant], Formulated with Sucrose) with Bio-Set from the European Union Commission. Representing the most advanced technology available for recombinant factor VIII product reconstitution and use, Kogenate Bayer with Bio-Set® becomes the first and only EU-approved, self- contained, fully assembled, needleless reconstitution system that virtually eliminates the risk of accidental needle-stick injuries during reconstitution. Bio-Set will be exclusively available with Kogenate Bayer for hemophilia A treatment and is expected to be available in Europe starting early in 2005. With its simplicity, safety, and convenience, Kogenate Bayer with Bio-Set represents a new standard for the reconstitution and delivery of factor VIII. Compared to currently available systems, Kogenate Bayer with Bio-Set involves fewer than half the components for reconstitution and offers a compact size for easy portability. It is the first and only EU-approved system to provide a prefilled syringe with 2.5 mL diluent, as small as any diluent volume currently available among recombinant factor VIII products. Kogenate Bayer with Bio-Set will advance patient safety as there is no exposure to needles during the reconstitution process, no latex utilized in the system, and minimal risk of contamination during reconstitution because of the special vacuum seal and fewer component parts. Finally, disposal is easier and safer because no needles are exposed. The European Commission also recently approved labeling amendments allowing room temperature storage for Kogenate Bayer. Kogenate Bayer (Antihemophilic Factor [Recombinant], Formulated with Sucrose) with Bio-Set can be stored at up to 25 degrees Celsius for up to two months. "By offering patient simplicity, improved safety and proven efficacy, Kogenate Bayer with Bio-Set is a major advance in hemophilia care," said Martin Dawkins, vice president, Bayer BP Europe. "This is a significant milestone for us at Bayer BP, as it represents the next step in our quest to advance care by providing products, technologies, and services that improve patient convenience and quality of life." The addition of a needleless reconstitution device further strengthens the excellent record of clinical safety and efficacy of Kogenate products, represented by more than 16 years of clinical experience and more than 5 billion units infused with no confirmed viral transmissions. The European Commission approval follows the recent approval of Kogenate FS with Bio-Set by Health Canada. Bio-Set is a registered trademark of Biodome.
SOURCE: Bayer Biological Products
|
