וילאט 1000

Nazione: Israele

Lingua: ebraico

Fonte: Ministry of Health

Principio attivo:

FACTOR VIII (HUMAN); VON WILLEBRAND FACTOR

Commercializzato da:

DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL

Codice ATC:

B02BD02

Forma farmaceutica:

אבקה וממס להכנת תמיסה להזרקה

Composizione:

VON WILLEBRAND FACTOR 1000 IU/VIAL; FACTOR VIII (HUMAN) 1000 IU/VIAL

Via di somministrazione:

תוך-ורידי

Tipo di ricetta:

מרשם נדרש

Prodotto da:

OCTAPHARMA AG, SWITZERLAND

Area terapeutica:

COAGULATION FACTOR VIII

Data dell'autorizzazione:

2018-11-30

Scheda tecnica

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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
sodium 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 is ineffective or
contra-indicated.
Haemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor
VIII deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be i