Wilate 500 500 IU VWF500 IU FVIII Powder and Solvent for Solution for Injection

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

coagulation factor VIII; Von Willebrand Factor

Dostupné z:

Pharmaniaga Marketing Sdn Bhd

INN (Medzinárodný Name):

coagulation factor VIII; Von Willebrand Factor

Počet v balení:

1vial Vials

Výrobca:

OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H.

Príbalový leták

Not Applicable

Súhrn charakteristických

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Mat-No./CAN/DataMatrix: XXXXXXX-XX (CODE IS A SAMPLE) / Version: 09 /
2020-09-28 / Product code: 189 / WILATE / MALAYSIA / 520 X 270 MM /
BLACK / SATZSTUDIO BORNGRÄBER / font size: 9PT
INSTRUCTION FOR USE
(SUMMARY OF PRODUCT CHARACTERISTICS)
1 NAME OF THE MEDICINAL PRODUCT
WILATE 500, 500 IU VWF/500 IU FVIII, powder and
solvent for solution for injection
WILATE 1000, 1000 IU VWF/1000 IU FVIII, powder and
solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Wilate is presented as a powder and solvent for solution for
injection.
Each vial contains nominally 500 IU/1000 IU human von Willebrand
factor (VWF
)
and human coagulation factor VIII (FVIII).
The product contains approximately 100 IU/ml human von Willebrand
factor when reconstituted with 5 ml/10 ml Water for Injections with
0.1 % Polysorbate 80.
The specific activity of Wilate is ≥ 67 IU VWF:RCo/mg protein.
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 product contains approximately 100 IU/ml human coagulation
factor VIII when reconstituted with 5 ml/10 ml Water for Injections
with 0.1% Polysorbate 80.
The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The specific activity of Wilate is ≥ 67 IU
FVIII:C/
mg protein.
Produced from the plasma of human donors.
Excipient(s) with known effect:
Wilate 500: 11.7 mg sodium per ml reconstituted solution (58.7 mg
sodium per vial).
Wilate 1000: 11.7 mg sodium per ml reconstituted
solution (117.3 mg per vial).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Freeze-dried powder: white or pale yellow powder or crumbly solid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Von Willebrand disease (VWD)
Prevention and treatment of haemorrhage or surgical bleeding
in von Willebrand disease (VWD), when desmopressin (DDAVP)
treatment alone