Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
vonicog alfa
Baxalta Innovations GmbH
B02BD10
vonicog alfa
Antihemorrhagics
von Willebrand Diseases
Veyvondi is indicated in adults (age 18 and older) with von Willebrand Disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or not indicated for the- Treatment of haemorrhage and surgical bleeding- Prevention of surgical bleeding.Veyvondi should not be used in the treatment of Haemophilia A.
Revision: 8
Authorised
2018-08-31
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VEYVONDI 650 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION VEYVONDI 1300 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION vonicog alfa 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 any further questions, ask your doctor. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What VEYVONDI is and what it is used for 2. What you need to know before you use VEYVONDI 3. How to use VEYVONDI 4. Possible side effects 5. How to store VEYVONDI 6. Contents of the pack and other information 1. WHAT VEYVONDI IS AND WHAT IT IS USED FOR VEYVONDI contains the active substance vonicog alfa, which is a recombinant human von Willebrand factor (rVWF). It behaves in the same way as natural human von Willebrand factor (VWF) in the body. VWF is the carrier molecule for coagulation factor VIII and is involved in blood clotting making platelets stick to wounds and so helps to form a blood clot. Lack of VWF increases the tendency to bleed. VEYVONDI is used to prevent and treat bleeding episodes, including bleeding during surgery, in adult patients (aged 18 years and older) with von Willebrand disease. It is used when treatment with another medicine, desmopressin, is not effective or cannot be given. Von Willebrand disease is an inherited bleeding disorder caused by the lack or an insufficient amount of von Willebrand factor. In patients with the disease the blood does not clot normally leading to a prolonged bleeding time. Administration of von Willebrand factor (VWF) allows for correction of von Willebrand factor deficiency. 2. WHAT YOU NEED TO KNOW B Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT VEYVONDI 650 IU powder and solvent for solution for injection VEYVONDI 1300 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION VEYVONDI 650 IU powder and solvent for solution for injection Each vial of powder contains nominally 650 International Units (IU) vonicog alfa. After reconstitution with the 5 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa. VEYVONDI 1300 IU powder and solvent for solution for injection Each vial of powder contains nominally 1300 International Units (IU) vonicog alfa. After reconstitution with the 10 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa. The specific activity of VEYVONDI is approximately 110 IU VWF:RCo/mg protein. The potency of VWF (IU) is measured using the European Pharmacopeia ristocetin cofactor activity assay (VWF: RCo). The ristocetin cofactor activity of recombinant human von Willebrand factor was determined against the International Standard for von Willebrand factor concentrate (WHO). Vonicog alfa is a purified recombinant human von Willebrand factor (rVWF). It is manufactured by recombinant DNA (rDNA) technology in the Chinese Hamster Ovary (CHO) cell line without the addition of any exogenous human-or animal-derived protein in the cell culture process, purification or final formulation. The product contains only trace amounts of human recombinant coagulation factor VIII (≤ 0.01 IU FVIII / IU VWF: RCo) as determined using the European Pharmacopoeia chromogenic assay for factor VIII (FVIII). Excipient with known effect Each 650 IU powder vial contains 5.2 mg sodium. Each 1300 IU powder vial contains 10.4 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is a white to off-white lyophilized powder The solvent is a clear and colourless solution. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Preve Aqra d-dokument sħiħ