Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
albutrepenonacog alfa
CSL Behring GmbH
B02BD04
albutrepenonacog alfa
Antihemorrhagics
Hemophilia B
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Revision: 12
Authorised
2016-05-11
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE USER IDELVION 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IDELVION 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IDELVION 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IDELVION 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IDELVION 3500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION albutrepenonacog alfa (recombinant coagulation factor IX) 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, pharmacist or nurse. 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 IDELVION is and what it is used for 2. What you need to know before you use IDELVION 3. How to use IDELVION 4. Possible side effects 5. How to store IDELVION 6. Contents of the pack and other information 1. WHAT IDELVION IS AND WHAT IT IS USED FOR WHAT IS IDELVION? IDELVION is a haemophilia medicine that replaces a natural blood clotting (coagulation) factor IX. The active substance in IDELVION is albutrepenonacog alfa (recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)). Factor IX is involved in blood clotting. Patients with haemophilia B have a lack of this factor which means that their blood does not clot as quickly as it should so there is an increased tendency to bleed. IDELVION works by replacing factor IX in haemophilia B patients to enable their blood to clot. WHAT IS IDELVION USED FOR? IDELVION is used to prevent or to halt bleeding caused by the lack of factor IX in patients of all age groups with haemophilia B (also called congenital factor IX deficiency or Christ Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT IDELVION 250 IU powder and solvent for solution for injection IDELVION 500 IU powder and solvent for solution for injection IDELVION 1000 IU powder and solvent for solution for injection IDELVION 2000 IU powder and solvent for solution for injection IDELVION 3500 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IDELVION 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with 2.5 ml water for injections the solution contains 100 IU/ml of albutrepenonacog alfa. IDELVION 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with 2.5 ml water for injections the solution contains 200 IU/ml of albutrepenonacog alfa. IDELVION 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with 2.5 ml water for injections the solution contains 400 IU/ml of albutrepenonacog alfa. IDELVION 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with 5 ml water for injections the solution contains 400 IU/ml of albutrepenonacog alfa. IDELVION 3500 IU powder and solvent for solution for injection Each vial contains nominally 3500 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with 5 ml water for injections the solution contains 700 IU/ml of albutrepenonacog alfa. The potency (IU) is Прочетете целия документ