Optivate

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Factor VIII; von Willebrand Factor (co-exist with Factor VIII)

Available from:

EURO ASIA MEDICO PTE. LTD.

ATC code:

B02BD06

Dosage:

100 iu/ml

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

Factor VIII 100 iu/ml; von Willebrand Factor (co-exist with Factor VIII) 260 iu/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Bio Products Laboratory

Authorization status:

ACTIVE

Authorization date:

2006-03-16

Summary of Product characteristics

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