Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
simoctocog alfa
Octapharma AB
B02BD02
simoctocog alfa
Antihemorrhagics
Hemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Vihuma can be used for all age groups.
Revision: 8
Authorised
2017-02-13
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER VIHUMA 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION VIHUMA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION VIHUMA 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION VIHUMA 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION VIHUMA 2500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION VIHUMA 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION VIHUMA 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 Vihuma is and what it is used for 2. What you need to know before you use Vihuma 3. How to use Vihuma 4. Possible side effects 5. How to store Vihuma 6. Contents of the pack and other information 1. WHAT VIHUMA IS AND WHAT IT IS USED FOR Vihuma contains the active substance human recombinant coagulation factor VIII (also called 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 does not work properly. Vihuma replaces the missing factor VIII so the blood can clot normally, and can be used in all age groups to treat and prevent bleeding in patients with haemophilia A. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIHUMA DO NOT USE VIHUMA • 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 this, ask your doctor. Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vihuma 250 IU powder and solvent for solution for injection Vihuma 500 IU powder and solvent for solution for injection Vihuma 1000 IU powder and solvent for solution for injection Vihuma 2000 IU powder and solvent for solution for injection Vihuma 2500 IU powder and solvent for solution for injection Vihuma 3000 IU powder and solvent for solution for injection Vihuma 4000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vihuma 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 250 IU contains approximately 100 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. Vihuma 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 500 IU contains approximately 200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. Vihuma 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 1000 IU contains approximately 400 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. Vihuma 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 2000 IU contains approximately 800 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. Vihuma 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 2500 IU contains approximately 1000 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. Vihuma 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human Pročitajte cijeli dokument