Active ingredient: Moroctocog alfa (recombinant coagulation factor VIII).

Indication: On-demand treatment & control of bleeding episodes; peri-op management; & routine prophylaxis to reduce frequency of bleeding episodes in adults & childn w/ hemophilia A (congenital factor VIII deficiency).

Dosage & Administration: Individualised dosage. Early hemarthrosis, minor muscle/oral bleeds 20-40 IU/dL 12-24 hrly for at least 1 day. Bleeding into muscles/oral cavity, mild head trauma 30-60 IU/dL 12-24 hrly for 3-4 days. GI, intracranial, intra-abdominal or intrathoracic bleeding, fractures 60-100 IU/dL 8-24 hrly. Minor surgery 30-60 IU/dL 12-24 hrly for 3-4 days. Tooth extraction 30-60 IU/dL single infusion + oral antifibrinolytic therapy w/in 1 hr. Major surgery 60-100 IU/dL 8-24 hrly. Routine prophylaxis Adult & adolescent ≥12 yr 30 IU/kg 3x wkly. Childn <12 yr Initially, 25 IU/kg every other day.