Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
Factor VIII; von Willebrand Factor (co-exist with Factor VIII)
EURO ASIA MEDICO PTE. LTD.
B02BD06
100 iu/ml
INJECTION, POWDER, FOR SOLUTION
Factor VIII 100 iu/ml; von Willebrand Factor (co-exist with Factor VIII) 260 iu/ml
INTRAVENOUS
Prescription Only
Bio Products Laboratory
ACTIVE
2006-03-16
SUMMARY OF PRODUCT CHARACTERISTICS OPTIVATE ® HIGH PURITY FACTOR VIII AND VON WILLEBRAND FACTOR CONCENTRATE 1. NAME OF THE MEDICINAL PRODUCT: Optivate (human factor VIII) 100 IU/ml, a powder for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Optivate is a concentrate of human coagulation factor VIII with associated von Willebrand factor (VWF) (the natural stabiliser for FVIII). There are no added proteins as stabilisers. The product is obtained from blood from screened donors. These donors are selected from the USA. Each vial contains nominally 250 IU, 500 IU or 1000 IU of human coagulation factor VIII. One ml of Optivate contains approximately 100 IU of human coagulation factor VIII after reconstitution with 2.5 ml (250 IU), 5 ml (500 IU) or 10 ml (1000 IU) of Sterilised Water for Injections, Ph. Eur. The factor VIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The factor VIII specific activity of Optivate is approximately 43 IU/mg of protein. The product contains approximately 172 IU VWF:RCo per ml when reconstituted with Sterilised Water for Injections as described above. The VWF potency (IU) is measured according to Ristocetin Cofactor activity (VWF:RCo), compared to the International Standard for von Willebrand Factor concentrate (WHO). The label on each vial states the assayed amounts of factor VIII and VWF Ristocetin Cofactor activities. For a full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM: Powder and solvent for solution for injection. 4. CLINICAL PARTICULARS: 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. The dosage and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and the patient’s clinical condition. POSOLOGY _O Baca dokumen lengkap