Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Nonacog gamma
Baxalta Innovations GmbH
B02BD04
nonacog gamma
Antihemorrhagics
Hemophilia B
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Revision: 11
Authorised
2014-12-19
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE USER RIXUBIS 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION RIXUBIS 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION RIXUBIS 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION RIXUBIS 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION RIXUBIS 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION nonacog gamma (recombinant human coagulation factor IX) 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 RIXUBIS is and what it is used for 2. What you need to know before you use RIXUBIS 3. How to use RIXUBIS 4. Possible side effects 5. How to store RIXUBIS 6. Contents of the pack and other information 1. WHAT RIXUBIS IS AND WHAT IT IS USED FOR RIXUBIS contains the active substance nonacog gamma and is a coagulation factor IX product. Factor IX is a normal constituent of human blood necessary for effective blood clotting. RIXUBIS is used in patients with haemophilia B (Christmas disease, an inherited bleeding disorder caused by lack of factor IX). It works by replacing the missing factor IX to enable the patient’s blood to clot. RIXUBIS is used for the treatment and prevention of bleeding in patients with haemophilia B of all age groups. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE RIXUBIS DO NOT USE RIXUBIS - if you are allergic to nonacog gamma or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hamster proteins WARNINGS AND PRECAUTIONS Allergic-type hypersensitivity reactions are poss Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT RIXUBIS 250 IU powder and solvent for solution for injection RIXUBIS 500 IU powder and solvent for solution for injection RIXUBIS 1000 IU powder and solvent for solution for injection RIXUBIS 2000 IU powder and solvent for solution for injection RIXUBIS 3000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION RIXUBIS 250 IU powder and solvent for solution for injection One vial contains nominally 250 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 50 IU/ml after reconstitution with 5 ml solvent. RIXUBIS 500 IU powder and solvent for solution for injection One vial contains nominally 500 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 100 IU/ml after reconstitution with 5 ml solvent. RIXUBIS 1000 IU powder and solvent for solution for injection One vial contains nominally 1000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 200 IU/ml after reconstitution with 5 ml solvent. RIXUBIS 2000 IU powder and solvent for solution for injection One vial contains nominally 2000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 400 IU/ml after reconstitution with 5 ml solvent. RIXUBIS 3000 IU powder and solvent for solution for injection One vial contains nominally 3000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 600 IU/ml after reconstitution with 5 ml solvent. The potency (IU) is determined using the European Pharmacopoeia one stage clotting assay. The specific activity of RIXUBIS is approximately 200-390 IU/mg protein. Nonacog gamma (recombinant coagulation factor IX) is a single-chain purified glycoprotein that has 415 amino acids. It is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. Excipient(s) with Прочетете целия документ