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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HUMAN VON, WILLEBRAND FACTOR, HUMAN COAGULATION, FACTOR XIII

Available from:

Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium

ATC code:

B02BD06

INN (International Name):

HUMAN VON WILLEBRAND FACTOR 1000 IU HUMAN COAGULATION FACTOR VIII 1000 IU

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

HUMAN VON WILLEBRAND FACTOR 1000 IU HUMAN COAGULATION FACTOR VIII 1000 IU

Prescription type:

POM

Therapeutic area:

ANTIHEMORRHAGICS

Authorization status:

Authorised

Authorization date:

2018-01-10

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
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.
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 used to treat and prevent bleeding in patients with
haemophilia A. This is a condition
in which bleeding can go on for longer than expected. It is due to an
inborn lack of factor VIII
in the blood.
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2. WHAT YOU NEED TO KNOW BEFORE YOU USE WILATE
DO NOT USE WILATE_ _
•
if you are allergic (hypersensitive) to

Summary of Product characteristics

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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).
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION