LYCOS RETRIEVER 
Antihemophilic Factor: Recombinant
built 275 days ago
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.
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Before you administer antihemophilic factor (recombinant), look at the solution closely. It should be clear and free of floating material. Gently squeeze the bag or observe the solution container to make sure there are no leaks. Do not use the solution if it is discolored, if it contains particles, or if the bag or container leaks. Use a new solution, but show the damaged one to your health care provider.
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The kit ... includes an infusion mat, tourniquet, butterfly needles, a biohazard disposal container, flush syringe and ReFacto(R) Antihemophilic Factor (Recombinant) R2 Kits for demonstration purposes only. The ReFacto R2 Kit allows patients to practice clotting factor preparation, in addition to infusion. The R2 kits include a prefilled diluent syringe, a vial adaptor and an infusion set. The Self-Infusion Training Kit also contains a CD-ROM for patients and their family members that explains the preparation process.
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Each bottle of antihemophilic factor (recombinant) has the rAHF content in international units per bottle stated on the label of the bottle. The reconstituted product must be administered intravenously by either direct syringe injection or drip infusion. The product must be administered within three hours after reconstitution.
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If you are receiving antihemophilic factor (recombinant) in your vein or under your skin, you need to know the symptoms of a catheter-related infection (an infection where the needle enters your vein or skin). If you experience any of these effects near your intravenous catheter, tell your health care provider as soon as possible:
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