OPTIVATE 500 I.U

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

FACTOR VIII; VON WILLEBRAND FACTOR

Disponible desde:

KAMADA LTD, ISRAEL

Código ATC:

B02BD06

formulario farmacéutico:

POWDER FOR SOLUTION FOR INJECTION

Composición:

FACTOR VIII 500 IU/VIAL; VON WILLEBRAND FACTOR 1300 IU/VIAL

Vía de administración:

I.V

tipo de receta:

Required

Fabricado por:

BIO PRODUCTS LABORATORY LIMITED, UK

Grupo terapéutico:

VON WILLEBRAND FACTOR AND COAGULA-TION FACTOR VIII IN COMBINATION

Área terapéutica:

VON WILLEBRAND FACTOR AND COAGULA-TION FACTOR VIII IN COMBINATION

indicaciones terapéuticas:

Treatment and prophylaxis of bleeding with haemophilia A (congenital factor VIII deficiency).

Fecha de autorización:

2013-12-31

Ficha técnica

1
Product Data Sheet
OPTIVATE
HIGH PURITY FACTOR VIII AND VON WILLEBRAND FACTOR CONCENTRATE
1.
NAME OF THE MEDICINAL PRODUCT:
Optivate 500 IU, powder for solution for injection
Optivate 1000 IU, 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.
Optivate 500 IU
Each vial contains nominally 500 IU human coagulation factor VIII.
Optivate contains approximately 100 IU/ml of human coagulation factor
VIII after
reconstitution.
Optivate 1000 IU
Each vial contains nominally 1000 IU human coagulation factor VIII.
Optivate contains approximately 100 IU/ml of human coagulation factor
VIII after
reconstitution.
The
factor
VIII
potency
(IU)
is
determined
using
the
European
Pharmacopoeia
chromogenic assay. The specific activity of Optivate is approximately
800 IU/mg
protein when VWF is discounted and approximately 43 IU/mg protein when
the
presence of VWF is considered in the calculation.
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.
Produced from the plasma of human donors.
Excipient with known effect:
Optivate contains approximately 320 mmol/1 (7.4 mg/ml) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM:
Powder and solvent for solution for injection.
Powder: White or pale yellow powder.
Solvent: Clear colourless liquid.
4.
CLINICAL PARTICULARS:
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor
VIII deficiency).
2
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 su