WILATE 1000/1000 International Unit Pdr+Solv for Soln for Inj

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FACTOR VIII (ANTIHAEMOPHILIC FACTOR), VON WILLEBRAND FACTOR HUMAN

Available from:

Octapharma Limited

ATC code:

B02BD06

INN (International Name):

FACTOR VIII (ANTIHAEMOPHILIC FACTOR), VON WILLEBRAND FACTOR HUMAN

Dosage:

1000/1000 International Unit

Pharmaceutical form:

Pdr+Solv for Soln for Inj

Prescription type:

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

Therapeutic area:

Blood coagulation factors

Authorization status:

Authorised

Authorization date:

2012-03-16

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER 
WILATE, 500 IU VWF/500 IU FVIII, powder and
solvent for solution for injection 
WILATE, 1000 IU VWF/1000 IU FVIII, powder and
solvent for solution for injection 
Human von Willebrand factor/human coagulation factor VIII 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE  BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
•  Please
keep this leaflet. You may need to read it again. 
•  If you have further questions, ask
your doctor or your pharmacist. 
•  This medicine has been prescribed for you only.
Do  not pass it on to others. It may harm 
them, even if their signs of illness are the same as yours. 
•  If you get any side effects talk to
your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 
WHAT IS IN THIS LEAFLET: 
1. What Wilate is and what it is used for 
2. What you need to know before you use Wilate 
3. How to use Wilate 
4. Possible side effects 
5. How to store Wilate 
6. Contents of the pack and other information 

1. 
WHAT WILATE IS AND WHAT IT IS USED FOR 
Wilate belongs to the pharmacotherapeutic group
of medicines called clotting factors and 
contains human von Willebrand factor

(VWF) and human blood coagulation factor VIII (FVIII). 
Together these two proteins are involved in blood clotting. 

Von Willebrand disease 
Wilate is used to treat and prevent bleeding in patients with
von Willebrand  disease (VWD), 
which in fact is a
family of related diseases. VWD is a disturbance of blood
coagulation where 
bleeding can go on for longer than expected.
This is either due to a lack of VWF in the blood or 
due to VWF that does not work the way it should. 
Haemophilia A 
Wilate is u

Summary of Product characteristics

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, produced from the plasma of human donors, is presented as a
powder and solvent for solution for injection
containing nominally 1000 IU human von Willebrand factor (VWF) and
human coagulation factor VIII (FVIII) per
vial.
The product contains approximately 100 IU/ml human von Willebrand
factor when reconstituted with 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 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 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 FVIII deficiency).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be 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 case any content remains, it should be
disposed of in accordance with local requirements.
Von Willebrand disease (VWD)
The ratio between VWF:RCo and F