Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Dried factor VIII fraction 500 [iU]; von Willebrand's factor : Ristocetin cofactor 1000 [iU]
CSL Behring (NZ) Ltd
Dried factor VIII fraction 500 IU
500 IU
Injection with diluent
Active: Dried factor VIII fraction 500 [iU] von Willebrand's factor : Ristocetin cofactor 1000 [iU] Excipient: Albumin Calcium chloride dihydrate Plasma protein Sodium chloride Sodium citrate dihydrate Sucrose Trometamol Water for injection
Combination pack, vial + diluent, 1 dose unit
General sale
General sale
CSL Behring (Australia) Pty Ltd
Biostate® is indicated for: · the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von Willebrand disease when desmopressin (DDAVP) treatment is ineffective or contraindicated
Package - Contents - Shelf Life: Combination pack, vial + diluent - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. one excursion of up to 6 months at 25°C allowed - Vial, glass, diluent - 10 mL - 60 months from date of manufacture stored at or below 25°C - Vial, glass, Lyophilised powder - 500 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. one excursion of up to 6 months at 25°C allowed
2002-06-12
NEW ZEALAND DATA SHEET Biostate NZ DS 20.00 Page 1 of 20 1 PRODUCT NAME Biostate ® 250 IU FVIII/500 IU VWF powder and diluent (5 mL) for solution for injection Biostate ® 500 IU FVIII/1000 IU VWF powder and diluent (5 mL) for solution for injection Biostate ® 500 IU FVIII/1000 IU VWF powder and diluent (10 mL) for solution for injection Biostate ® 1000 IU FVIII/2000 IU VWF powder and diluent (10 mL) for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Biostate ® is a high purity, sterile, powder for injection containing a human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF) complex. Biostate ® is manufactured from human plasma donated by New Zealand’s voluntary non-remunerated donors. The FVIII/VWF complex in Biostate ® is purified from cryoprecipitate using selective precipitation and size exclusion chromatography steps. It contains other proteins such as fibrinogen, fibronectin, immunoglobulins (IgA, IgM, IgG) and transforming growth factor-β (TGF-β) all of which are present at significantly lower levels than in normal plasma. Biostate ® 250 IU FVIII/500 IU VWF powder and diluent for solution for injection One vial of powder contains nominally: - 250 IU human coagulation factor VIII (FVIII). - 500 IU human von Willebrand factor (VWF). After reconstitution with the 5 mL water for injections provided, the solution contains 50 IU/mL of FVIII and 100 IU/mL of VWF. Biostate ® 500 IU FVIII/1000 IU VWF powder and diluent for solution for injection One vial of powder contains nominally: - 500 IU human coagulation factor VIII (FVIII). - 1000 IU human von Willebrand factor (VWF). After reconstitution with the 10 mL water for injections provided, the solution contains 50 IU/mL of FVIII and 100 IU/mL of VWF. Biostate ® 500 IU FVIII/1000 IU VWF powder and diluent for solution for injection One vial of powder contains nominally: - 500 IU human coagulation factor VIII (FVIII). - 1000 IU human von Willebrand factor (VWF). After reconstitution with the 5 mL water for injecti Lugege kogu dokumenti