WILATE 500

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

FACTOR VIII (HUMAN); VON WILLEBRAND FACTOR

Tillgänglig från:

DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL

ATC-kod:

B02BD02

Läkemedelsform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Sammansättning:

VON WILLEBRAND FACTOR 500 IU/VIAL; FACTOR VIII (HUMAN) 500 IU/VIAL

Administreringssätt:

I.V

Receptbelagda typ:

Required

Tillverkad av:

OCTAPHARMA AG, SWITZERLAND

Terapiområde:

COAGULATION FACTOR VIII

Terapeutiska indikationer:

Von Willebrand disease (VWD) :Prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contra-indicated.Haemophilia A :Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency).

Tillstånd datum:

2018-11-30

Produktens egenskaper

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_Page 1/13 _
The format of this leaflet has been defined by the MOH and its content
has been checked
and approved
12.2013
1
NAME OF THE MEDICINAL PRODUCT
WILATE 500, 500 IU FVIII/500 IU VWF, POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION
WILATE 1000, 1000 IU FVIII/1000 IU VWF, POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Wilate, produced from the plasma of human donors, is presented as a
powder and solvent
for solution for injection containing nominally 500 IU/1000 IU human
coagulation factor
VIII and human von Willebrand factor (VWF) per vial.
The
product
contains
approximately
100
IU/ml
human
von
Willebrand
factor
when
reconstituted with 5 ml/10 ml Water for Injections with 0.1 %
Polysorbat 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 FVIII potency (IU) is determined using the European Pharmacopoeia
chromogenic
assay. The specific activity of Wilate is

67 IU FVIII:C/mg protein.
For a full list of excipients, see 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 is ineffective or
contra-indicated.
Haemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital FVIII
deficiency).
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_Page 2/13 _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of coagulation disorders. The product is of single us