KOATE-DVI SUMMARY
Antihemophilic Factor (Human), Koàte®-DVI, is a sterile, stable, purified, dried concentrate of human Antihemophilic Factor (AHF, factor VIII, AHG) which has been treated with tri-n-butyl phosphate (TNBP) and polysorbate 80 and heated in lyophilized form in the final container at 80°C for 72 hours. Koàte-DVI is intended for use in therapy of classical hemophilia (hemophilia A).
Koàte-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII. Koàte-DVI provides a means of temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia.
Koàte-DVI contains naturally occurring von Willebrand's factor, which is co-purified as part of the manufacturing process.
Koàte-DVI has not been investigated for efficacy in the treatment of von Willebrand's disease, and hence is not approved for such usage.
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