Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
rurioctocog alfa pegol
Baxalta Innovations GmbH
B02BD02
rurioctocog alfa pegol
Antihemorrhagics
Hemophilia A
Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
Revision: 10
Authorised
2018-01-08
108 B. PACKAGE LEAFLET 109 PACKAGE LEAFLET: INFORMATION FOR THE USER ADYNOVI 250 IU / 5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ADYNOVI 500 IU / 5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ADYNOVI 1 000 IU / 5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ADYNOVI 2 000 IU / 5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ADYNOVI 3 000 IU / 5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 ADYNOVI is and what it is used for 2. What you need to know before you use ADYNOVI 3. How to use ADYNOVI 4. Possible side effects 5. How to store ADYNOVI 6. Contents of the pack and other information 1. WHAT ADYNOVI IS AND WHAT IT IS USED FOR ADYNOVI contains the active substance rurioctocog alfa pegol, pegylated human coagulation factor VIII. The human coagulation factor VIII has been modified to prolong its duration of action. Factor VIII is necessary for the blood to form clots and stop bleedings. In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly. ADYNOVI is used for the treatment and prevention of bleeding in patients from 12 years of age with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII) Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection ADYNOVI 1 000 IU / 5 ml powder and solvent for solution for injection ADYNOVI 2 000 IU / 5 ml powder and solvent for solution for injection ADYNOVI 3 000 IU / 5 ml powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 50 IU/ml after reconstitution with 5 ml solvent. ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 100 IU/ml after reconstitution with 5 ml solvent. ADYNOVI 1 000 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 1 000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 200 IU/ml after reconstitution with 5 ml solvent. ADYNOVI 2 000 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 2 000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 400 IU/ml after reconstitution with 5 ml solvent. ADYNOVI 3 000 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 3 000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 600 IU/ml after reconstitution with 5 ml solvent. The potency (International Units) is determined usin Pročitajte cijeli dokument