Antihemophilic Factor (Human) (AHF), Hemofil M, Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 15 AHF International Units/mg of total protein. When reconstituted with the appropriate volume of diluent, it contains approximately 12.5 mg/mL Albumin (Human), 1.5 mg/mL polyethylene glycol (3350), 0.055 M histidine and 0.030 M glycine as stabilizing agents. In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein. It also contains, per AHF International Unit, not more than 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). See Clinical PHARMACOLOGY.

Hemofil M AHF is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification. Source material may be provided by other US licensed manufacturers. Hemofil M AHF also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. However, no procedure has been shown to be totally effective in removing viral infectivity from coagulation factor products.

Each bottle of Hemofil M AHF is labeled with the AHF activity expressed in International Units per bottle, which is referenced to the WHO International Standard.

Hemofil M AHF is to be administered only intravenously.

Bookmark this page: