Koate-DVI Description

Each vial of Koate-DVI contains the labeled amount of antihemophilic factor activity in international units (iu). One iu, as defined by the World Health Organization standard for blood coagulation factor VIII (human) is approximately equal to the level of AHF found in 1 mL of fresh pooled human plasma. The final product when reconstituted as directed contains polyethylene glycol (PEG) not more than (NMT) 1500 mcg/mL, glycine NMT 0.05 M, polysorbate 80 NMT 25 mcg/mL, tri-n-butyl phosphate (TNBP) NMT 5 mcg/g, calcium NMT 3mM, aluminum NMT 1 mcg/mL, histidine NMT 0.06 M, and albumin (human) NMT 10 mg/mL.
Koate-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 hrs. Koate-DVI is intended for use in therapy of classical hemophilia (hemophilia A).
Koate-DVI is purified from the cold insoluble fraction of pooled fresh-frozen plasma by modification and refinements of the methods first described by Hershgold, Pool and Pappenhagen. Koate-DVI contains purified and concentrated factor VIII. The factor VIII is 300-1000 times purified over whole plasma. Part of the fractionation may be performed by another licensed manufacturer. When reconstituted as directed, Koate-DVI contains approximately 50-150 times as much factor VIII as an equal volume of fresh plasma. The specific activity, after addition of albumin (human), is in the range of 9-22 iu/mg protein. Koate-DVI must be administered by the IV route.