Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
simoctocog alfa
Octapharma AB
B02BD02
simoctocog alfa
Blood coagulation factors
Hemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Nuwiq can be used for all age groups.
Revision: 13
Authorised
2014-07-22
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE USER NUWIQ 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NUWIQ 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NUWIQ 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NUWIQ 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NUWIQ 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NUWIQ 2500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NUWIQ 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NUWIQ 4000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION simoctocog alfa (recombinant human coagulation factor VIII) 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 Nuwiq is and what it is used for 2. What you need to know before you use Nuwiq 3. How to use Nuwiq 4. Possible side effects 5. How to store Nuwiq 6. Contents of the pack and other information 1. WHAT NUWIQ IS AND WHAT IT IS USED FOR Nuwiq contains the active substance human recombinant coagulation factor VIII (simoctocog alfa). Factor VIII is necessary for the blood to form clots and stop bleeding. In patients with haemophilia A (inborn factor VIII deficiency), factor VIII is missing or not working properly. Nuwiq replaces the missing factor VIII and is used for treatment and prevention of bleeding in patients with haemophilia A and can be used for all age groups. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NUWIQ DO NOT USE NUWIQ • if you are allergic to the active substance simoctocog alfa or any of the other ingredients of this medicine (listed in section 6). If you are unsure about Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nuwiq 250 IU powder and solvent for solution for injection Nuwiq 500 IU powder and solvent for solution for injection Nuwiq 1000 IU powder and solvent for solution for injection Nuwiq 1500 IU powder and solvent for solution for injection Nuwiq 2000 IU powder and solvent for solution for injection Nuwiq 2500 IU powder and solvent for solution for injection Nuwiq 3000 IU powder and solvent for solution for injection Nuwiq 4000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nuwiq 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa. Nuwiq 250 IU contains approximately 100 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. Nuwiq 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa. Nuwiq 500 IU contains approximately 200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. Nuwiq 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa. Nuwiq 1000 IU contains approximately 400 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. Nuwiq 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU human coagulation factor VIII (rDNA), simoctocog alfa. Nuwiq 1500 IU contains approximately 600 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. Nuwiq 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa. Nuwiq 2000 IU contains approximately 800 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. Nuwiq 2500 IU powder and solvent for solution for injection Ea Les hele dokumentet