Wilate 500 powder and solvent for solution for infusion vials

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Factor VIII; von Willebrand factor

Предлага се от:

Octapharma Ltd

АТС код:

B02BD06

INN (Международно Name):

Factor VIII; von Willebrand factor

дозиране:

500unit ; 500unit

Лекарствена форма:

Powder and solvent for solution for infusion

Начин на приложение:

Intravenous

Клас:

No Controlled Drug Status

Вид предписание :

Never Valid To Prescribe As A VMP

Каталог на резюме:

BNF: ; GTIN: 5060237670334

Листовка

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 (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 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 FVIII in the blood.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE WILATE
DO NOT USE WILATE
• if you are allergic (hypersensitive) to human von Willebrand
facto

Данни за продукта

OBJECT 1
WILATE
Summary of Product Characteristics Updated 15-Dec-2014 | Octapharma
Limited
1. Name of the medicinal product
Wilate 500, 500 IU VWF/500 IUFVIII, powder and solvent for solution
for injection
Wilate 1000, 1000 IU VWF/1000 IUFVIII, 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 500 IU/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 5
ml/10 ml Water for Injections with 0.1 % Polysorbat 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 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