וילאט 500

Χώρα: Ισραήλ

Γλώσσα: Εβραϊκά

Πηγή: Ministry of Health

Δραστική ουσία:

FACTOR VIII (HUMAN); VON WILLEBRAND FACTOR

Διαθέσιμο από:

DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL

Φαρμακολογική κατηγορία (ATC):

B02BD02

Φαρμακοτεχνική μορφή:

אבקה וממס להכנת תמיסה להזרקה

Σύνθεση:

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

Οδός χορήγησης:

תוך-ורידי

Τρόπος διάθεσης:

מרשם נדרש

Κατασκευάζεται από:

OCTAPHARMA AG, SWITZERLAND

Θεραπευτική περιοχή:

COAGULATION FACTOR VIII

Ημερομηνία της άδειας:

2018-11-30

Αρχείο Π.Χ.Π.

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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