KOGENATE FS Antihaemophilic Factor (Recombinant) is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. KOGENATE FS is intended for use in the treatment of bleeding in patients with classical haemophilia (haemophilia A). KOGENATE FS is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII (FVIII) gene has been introduced.
KOGENATE FS is a highly purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as FVIII derived from human plasm, compared to its predecessor product (KOGENATE manufactured with Human Albumin).
KOGENATE FS incorporates a revised purification and formulation process that eliminates the addition of Albumin (Human).
Indicated in congenital Factor VIII deficiency (haemophilia A) for the treatment and prophylaxis of bleeding (in previously treated and untreated patients).
Indicated in patients with Factor VIII inhibitors (neutralising antibodies) who continue to respond to KOGENATE FS (i.e. achievement of haemostasis)
KOGENATE FS does not contain von Willebrand factor and hence is NOT indicated in von Willebrand’s disease.
KOGENATE® FS 250, POWDER FOR INJECTION
KOGENATE® FS 500, POWDER FOR INJECTION
KOGENATE® FS 1000, POWDER FOR INJECTION
DILUENT FOR KOGENATE® FS: Sterile Water for Injection (SWI)