Wilate, 1000 IU VWF/1000 IU FVIII, powder and solvent for solution for injection

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Human factor viii; Von willebrand factor human

Commercializzato da:

Octapharma (IP) SPRL

Codice ATC:

B02BD; B02BD06

INN (Nome Internazionale):

Human factor viii; Von willebrand factor human

Dosaggio:

1000/1000 international unit(s)

Forma farmaceutica:

Powder and solvent for solution for injection

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Blood coagulation factors; von Willebrand factor and coagulation factor VIII in combination

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2012-03-16

Foglio illustrativo

Wilate
can
be
stored
at
room
temperature
(max.
+25°C) for 2 months. In this case the shelf-life expires
2 months after the product has been taken out of the refrigerator for
the first time. The new shelf-life has to be noted on the outer carton
by you.
The powder should be dissolved only directly before injection. The
stability of the solution has been demonstrated for 4 hours at room
temperature. Nevertheless, to prevent contamination, the solution
should be used immediately and on one occasion only.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT WILATE CONTAINS
− The active substances are human von Willebrand factor and
human coagulation factor VIII
− The
other
ingredients
are
sodium
chloride,
glycine,
sucrose,
sodium citrate and calcium chloride. Solvent: water for injections
with 0.1% Polysorbate 80
WHAT WILATE LOOKS LIKE AND CONTENTS OF THE PACK
Freeze-dried powder: white or pale yellow powder or crumbly solid
Reconstituted solution: should be clear or slightly opalescent
Wilate is supplied as a powder and solvent for solution for injection.
It comes in 2 pack sizes:
• Wilate, 500 IU VWF and 500 IU FVIII, powder and solvent for
solution for injection, contains nominally 500 IU human von
Willebrand factor and 500 IU human coagulation factor VIII per
vial. The product contains approximately 100 IU/ml human von
Willebrand factor and 100 IU/ml human coagulation factor VIII
when reconstituted with 5 ml of Water for Injections with 0.1%
Polysorbate 80 (Solvent).
• Wilate, 1000 IU VWF and 1000 IU FVIII, powder and solvent for
solution for injection, contains nominally 1000 IU human von
Willebrand factor and 1000 IU human coagulation factor VIII per
vial. The product contains approximately 100 IU/ml human von
Willebrand factor and 100 IU/ml human coagulation factor VIII
when reconstituted with 10 ml of Water for Injections

Scheda tecnica

Health Products Regulatory Authority
14 December 2022
CRN00D55X
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Wilate, 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 ³ 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 ³ 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 under the supervision of a phy