CSL Bulk Human Coagulation Factor VIII 500 IU (100 IU/mL) / von Willebrand factor 1200 IU powder for injection vial

Active ingredient:

Von willebrand factor, Quantity: 1200 IU; Factor VIII, Quantity: 500 IU

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

Factor VIII,Von willebrand factor

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sucrose; trometamol; sodium chloride; Albumin; sodium citrate dihydrate; calcium chloride dihydrate

Administration route:

Intravenous

Therapeutic indications:

von Willebrand disease (VWD) - Treatment of haemorrhage or prevention and treatment of surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Haemophilia A (congenital FVIII deficiency) - Prophylaxis and treatment of bleeding in patients with haemophilia A.

Product summary:

Visual Identification: A white or pale yellow, hygroscopic powder or friable solid; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-09-02