Voncento 500unit1,200unit powder and solvent for solution for injection vials

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Factor VIII; von Willebrand factor

Disponibbli minn:

CSL Behring UK Ltd

Kodiċi ATC:

B02BD06

INN (Isem Internazzjonali):

Factor VIII; von Willebrand factor

Dożaġġ:

500unit ; 1200unit

Għamla farmaċewtika:

Powder and solvent for solution for injection

Rotta amministrattiva:

Intravenous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Never Valid To Prescribe As A VMP

Sommarju tal-prodott:

BNF: 02110000; GTIN: 5028360001067

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 replacement of
VWF and FVIII by Voncento will temporarily repair the blood clotting
mechanisms.
As Voncento
contains both FVIII and VWF, it is important to know which factor you
most need. If you have haemophilia A your doctor will prescribe

Karatteristiċi tal-prodott

OBJECT 1
VONCENTO 500 IU FVIII / 1200 IU VWF (5 ML
SOLVENT) POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION
Summary of Product Characteristics Updated 09-May-2018 | CSL Behring
UK Limited
1. Name of the medicinal product
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 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 the10 ml water for injections provided, the
solution contains 100 IU/ml of FVIII
and 240 IU/ml of VWF.
Excipient with known effect:
Voncento contains approximately 128.2 mmol/l (2.95 mg/ml) of sodium.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Powder and solvent for solution for injection/infusion.
White powder and clear, colourless solvent for solution for
injection/infusion.
* The FVIII potency (IU) is determined using the European
Pharmacopoeia chromogenic assay. The
specific FVIII activity of Voncento, prior to the addition of
stabiliser, is approximately 70 IU of FVIII/mg
protein.
** Produced from plasma of human donors
***The VWF activity is determined using the WHO Standard for VWF. The
specific VWF activity of
Voncento, prior to the addition of stabiliser, is approximately 100 IU
of VWF/mg protein.
4. Clinical particulars
4.1 Therapeutic indications
Voncento can be used for all age groups.
von Wi