KOĀTE®-DVI

FDA INDICATION: Treatment of hemophilia A in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII. Koāte-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. Koāte-DVI contains naturally occurring von Willebrand factor, which is co-purified as part of the manufacturing process. Package Insert

CLASS: Plasma-Derived

DISTRIBUTOR: Kedrion Biopharma

ASSAY SIZE (IU): FVIII: 250, 500, 1000

DILUENT SIZE: 5.0 mL (250 IU FVIII, 500 IU FVIII), 10.0 mL (1000 IU FVIII)

MIXING DEVICE: Mix2Vial®

ROOM TEMPERATURE STORAGE: 6 months

HALF-LIFE: Mean 16.12 hours (FVIII)

OTHER WEBSITES: kedrionusa.com, Koāte-DVI