Voncento

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Human coagulation factor VIII, human von willebrand factor

Saadav alates:

CSL Behring GmbH

ATC kood:

B02BD06

INN (Rahvusvaheline Nimetus):

human coagulation factor VIII / human von willebrand factor

Terapeutiline rühm:

Blood coagulation factors, von Willebrand factor and coagulation factor VIII in combination, Antihemorrhagics

Terapeutiline ala:

Hemophilia A; von Willebrand Diseases

Näidustused:

Von Willebrand disease (VWD)Prophylaxis and treatment of haemorrhage or surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.Haemophilia A (congenital factor-VIII deficiency)Prophylaxis and treatment of bleeding in patients with haemophilia A.

Toote kokkuvõte:

Revision: 15

Volitamisolek:

Authorised

Loa andmise kuupäev:

2013-08-12

Infovoldik

41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE USER
VONCENTO 250 IU FVIII / 600 IU VWF (5 ML SOLVENT) POWDER AND SOLVENT
FOR SOLUTION FOR
INJECTION/INFUSION
VONCENTO 500 IU FVIII / 1200 IU VWF(10 ML SOLVENT) POWDER AND SOLVENT
FOR SOLUTION FOR
INJECTION/INFUSION
VONCENTO 500 IU FVIII / 1200 IU VWF (5 ML SOLVENT) POWDER AND SOLVENT
FOR SOLUTION FOR
INJECTION/INFUSION
VONCENTO 1000 IU FVIII / 2400 IU VWF (10 ML SOLVENT) POWDER AND
SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION
human coagulation factor VIII,
human von Willebrand factor
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have further questions, ask your doctor, your nurse or your
pharmacist.

This medicine has been prescribed for you. 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, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Voncento is and what it is used for
2.
What you need to know before you use Voncento
3.
How to use Voncento
4.
Possible side effects
5.
How to store Voncento
6.
Contents of the pack and other information
1.
WHAT VONCENTO IS AND WHAT IT IS USED FOR
The product is made from human plasma (the liquid part of the blood)
and contains the active
substances called human coagulation factor VIII (FVIII) and human von
Willebrand factor (VWF).
Voncento is used for all age groups to prevent or to halt bleeding
caused by the lack of VWF in von
Willebrand disease (VWD) and the lack of FVIII in haemophilia A.
Voncento is only used when
treatment with another medicine, desmopressin, is not effective alone
or cannot be given.
VWF and FVIII are involved in blood clotting. Lack of either factor
means that blood does not clot as
quickly as it should so there is an increased tendency to bleed. The
replacemen

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Voncento 250 IU FVIII / 600 IU VWF (5 ml solvent) powder and solvent
for solution for
injection/infusion
Voncento 500 IU FVIII /1200 IU VWF (10 ml solvent) powder and solvent
for solution for
injection/infusion
Voncento 500 IU FVIII / 1200 IU VWF (5 ml solvent) powder and solvent
for solution for
injection/infusion
Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and
solvent for solution for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Voncento 250 IU FVIII / 600 IU VWF powder and solvent for solution for
injection/infusion
One vial of powder contains nominally:
-
250 IU* human coagulation factor VIII** (FVIII).
-
600 IU*** human von Willebrand factor** (VWF).
After reconstitution with the 5 ml water for injections provided, the
solution contains 50 IU/ml of
FVIII and 120 IU/ml of VWF.
Voncento 500 IU FVIII / 1200 IU VWF powder and solvent for solution
for injection/infusion
One vial of powder contains nominally:
-
500 IU* human coagulation factor VIII** (FVIII).
-
1200 IU*** human von Willebrand factor** (VWF).
After reconstitution with the 10 ml water for injections provided, the
solution contains 50 IU/ml of
FVIII and 120 IU/ml of VWF.
Voncento 500 IU FVIII / 1200 IU VWF powder and solvent for solution
for injection/infusion
One vial of powder contains nominally:
-
500 IU* human coagulation factor VIII** (FVIII).
-
1200 IU*** human von Willebrand factor** (VWF).
After reconstitution with the 5 ml water for injections provided, the
solution contains 100 IU/ml of
FVIII and 240 IU/ml of VWF.
Voncento 1000 IU FVIII / 2400 IU VWF powder and solvent for solution
for injection/infusion
One vial of powder contains nominally:
-
1000 IU* human coagulation factor VIII** (FVIII).
-
2400 IU*** human von Willebrand factor** (VWF).
After reconstitution with the 10 ml water for injections provided, the
solution contains 100 IU/ml of
FVIII and 240 IU/ml of VWF.
_________________________________________
* The FVIII poten