Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
Human coagulation factor VIII, human von willebrand factor
CSL Behring GmbH
B02BD06
human coagulation factor VIII / human von willebrand factor
Blood coagulation factors, von Willebrand factor and coagulation factor VIII in combination, Antihemorrhagics
Hemophilia A; von Willebrand Diseases
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.
Revision: 15
Authorised
2013-08-12
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 Lees het volledige document
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 Lees het volledige document