WILATE 450 450 Millilitre Pdr+Solv for Soln for Inj
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
31-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
FACTOR VIII, HUMAN VON WILLEBRAND FACTOR HUMAN
Available from:
Octapharma Limited
INN (International Name):
FACTOR VIII, HUMAN VON WILLEBRAND FACTOR HUMAN
Dosage:
450 Millilitre
Pharmaceutical form:
Pdr+Solv for Soln for Inj
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Wilate 450, 450 IU FVIII / 400 IU VWF, powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Wilate is presented as a powder and solvent for solution for injection containing nominally 450 IU human coagulation
factor VIII and 400 IU human von Willebrand factor (VWF) per vial.
The product contains approximately 80 IU/ml human von Willebrand factor when reconstituted with 5 ml Water for
Injections with 0.1 % Polysorbat 80.
The specific activity of Wilate is approximately
53 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 90 IU/ml human coagulation factor VIII when reconstituted with 5 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 approximately
60 IU FVIII:C/mg protein.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
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).
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 use and the full content of the vial should be administered. In
Read the complete document
