Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany
Voncento 250 IU FVIII/600 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion.
Voncento 500 IU FVIII/200 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.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection/infusion. White powder and clear, colourless solvent for solution for injection/infusion. |
One vial of powder contains nominally:
After reconstitution with the 5 ml water for injections provided, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
One vial of powder contains nominally:
After reconstitution with the 10 ml water for injections provided, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
One vial of powder contains nominally:
After reconstitution with the 5 ml water for injections provided, the solution contains 100 IU/ml of FVIII and 240 IU/ml of VWF.
One vial of powder contains nominally:
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 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.
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.
| Active Ingredient | Description | |
|---|---|---|
| Coagulation factor VIII |
Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X (factor Xa). Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. |
|
| Von Willebrand factor |
Administration of von Willebrand factor allows correction of the haemostatic abnormalities exhibited by patients who suffer from von Willebrand factor deficiency. |
| List of Excipients |
|---|
|
Powder: Calcium chloride Solvent: Water for injections |
Powder (250 IU/600 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
One pack contains:
1 vial with powder
1 vial with 5 ml water for injections
1 filter transfer device 20/20
One inner box containing:
1 disposable 10 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Powder (500 IU/1200 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
10 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
One pack contains:
1 vial with powder
1 vial with 10 ml water for injections
1 filter transfer device 20/20
One inner box containing:
1 disposable 10 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Powder (500 IU/1200 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
One pack contains:
1 vial with powder
1 vial with 5 ml water for injections
1 filter transfer device 20/20
One inner box containing:
1 disposable 10 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Powder (1000 IU/2400 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
10 ml of solvent in a vial (type I glass) with a stopper (rubber) a disc (plastic) and a cap (aluminium).
One pack contains:
1 vial with powder
1 vial with 10 ml water for injections
1 filter transfer device 20/20
One inner box containing:
1 disposable 10 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Not all pack sizes may be marketed.
CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany
EU/1/13/857/001
EU/1/13/857/002
EU/1/13/857/003
EU/1/13/857/004
Date of first authorisation: 12 August 2013
Date of latest renewal: 26 April 2018
| Drug | Countries | |
|---|---|---|
| VONCENTO | Austria, Brazil, Cyprus, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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