Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
Octocog alfa
Bayer AG
B02BD02
octocog alfa
Antihemorrhagics
Hemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Iblias can be used for all age groups.
Revision: 4
Withdrawn
2016-02-18
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE USER IBLIAS 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IBLIAS 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IBLIAS 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IBLIAS 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IBLIAS 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Recombinant human coagulation factor VIII (octocog alfa) 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Iblias is and what it is used for 2. What you need to know before you use Iblias 3. How to use Iblias 4. Possible side effects 5. How to store Iblias 6. Contents of the pack and other information 1. WHAT IBLIAS IS AND WHAT IT IS USED FOR Iblias is a medicine that contains the active substance human recombinant coagulation factor VIII, also called octocog alfa. Iblias is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process. Factor VIII is a protein naturally found in the blood that helps to clot it. Iblias is used for treatment and prevention of bleeding in adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IBLIAS DO NOT USE IBLIAS if you are all Přečtěte si celý 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 Iblias 250 IU powder and solvent for solution for injection Iblias 500 IU powder and solvent for solution for injection Iblias 1000 IU powder and solvent for solution for injection Iblias 2000 IU powder and solvent for solution for injection Iblias 3000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains nominally 250/500/1000/2000/3000 IU human coagulation factor VIII. One mL Iblias 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections. One mL Iblias 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections. One mL Iblias 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections. One mL Iblias 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections. One mL Iblias 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections. The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Iblias is approximately 4000 IU/mg protein. Octocog alfa (Full length recombinant human coagulation factor VIII (rDNA)) is a purified protein that has 2,332 amino acids. It is produced by recombinant DNA technology in baby hamster kidney ce Přečtěte si celý dokument