Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
turoctocog alfa
Novo Nordisk A/S
B02BD02
turoctocog alfa
coagulation factor VIII
Hemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.
Revision: 13
Authorised
2013-11-13
46 B. PACKAGE LEAFLET 47 PACKAGE LEAFLET: INFORMATION FOR THE USER NOVOEIGHT 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NOVOEIGHT 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NOVOEIGHT 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NOVOEIGHT 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NOVOEIGHT 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NOVOEIGHT 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION turoctocog alfa (human coagulation factor VIII (rDNA)) 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NovoEight is and what it is used for 2. What you need to know before you use NovoEight 3. How to use NovoEight 4. Possible side effects 5. How to store NovoEight 6. Contents of the pack and other information 1. WHAT NOVOEIGHT IS AND WHAT IT IS USED FOR NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII. Factor VIII is a protein naturally found in the blood that helps it to clot. NovoEight is used to treat and prevent bleeding episodes in patients with haemophilia A (inborn factor VIII deficiency) and can be used for all age groups. In patients with haemophilia A, factor VIII is missing or not working properly. NovoEight replaces this faulty or missing ‘factor VIII’ and helps blood to form clots at the site of bleeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOEIGHT DO NOT USE NOVOEIGHT: • if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6) • if you are allergic to Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT NovoEight 250 IU powder and solvent for solution for injection NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NovoEight 250 IU powder and solvent for solution for injection. Each powder vial contains nominally 250 IU human coagulation factor VIII (rDNA), turoctocog alfa. After reconstitution NovoEight contains approximately 62.5 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa. NovoEight 500 IU powder and solvent for solution for injection. Each powder vial contains nominally 500 IU human coagulation factor VIII (rDNA), turoctocog alfa. After reconstitution NovoEight contains approximately 125 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa. NovoEight 1000 IU powder and solvent for solution for injection. Each powder vial contains nominally 1000 IU human coagulation factor VIII (rDNA), turoctocog alfa. After reconstitution NovoEight contains approximately 250 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa. NovoEight 1500 IU powder and solvent for solution for injection. Each powder vial contains nominally 1500 IU human coagulation factor VIII (rDNA), turoctocog alfa. After reconstitution NovoEight contains approximately 375 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa. NovoEight 2000 IU powder and solvent for solution for injection. Each powder vial contains nominally 2000 IU human coagulation factor VIII (rDNA), turoctocog alfa. After reconstitution NovoEight contains approximately 500 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa. NovoEight 3000 IU powder and solvent for solution for injection. Each powder vial contains nominally 3000 IU human Прочетете целия документ