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ReFacto® Antihemophilic Factor (Recombinant) R2 Kit Now Available
Wyeth Pharmaceuticals recently received approval from the U.S. Food and Drug Administration for the ReFacto® Antihemophilic Factor (Recombinant) R2 Kit, the first needle-less reconstitution device with a prefilled diluent syringe. As of November 2, 2004, we began shipping the ReFacto R2 Kit to hemophilia treatment centers and home health care companies.
How the R2 Kit Works The adapter is placed on the vial of ReFacto, and the vial adapter and the prefilled syringe allow ReFacto to be reconstituted without the risk of needle exposure. Compared with the previous method for reconstituting ReFacto, the R2 kit provides a faster and simpler infusion process. The ReFacto R2 kit contains:
- Product information and easy to understand instructions
- 1 prefilled diluent syringe
- 1 single-use vial of ReFacto containing either 250, 500, 1000, or 2000 IU
- 1 vial adapter
- 2 alcohol swabs
- 1 sterile infusion set
Wyeth remains committed to the hemophilia community and continues to look for ways to improve lives through innovation. The ReFacto R2 Kit is the latest example of our commitment to providing tools that allow patients and their families to more conveniently incorporate hemophilia treatment into their everyday lives. We hope that it will enable ReFacto patients to spend less time infusing and more time living their lives.
About ReFacto ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical and short-term routine prophylaxis in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.
As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions. The remote possibility exists for hypersensitivity to non-human mammalian proteins. Please see Prescribing Information.
Please feel free to contact the Wyeth Hemophilia Hotline at 1-888-999-2349 with questions.
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