Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
Nonacog beta pegol
Novo Nordisk A/S
B02BD04
nonacog beta pegol
Antihemorrhagics
Hemophilia B
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency)., Refixia can be used for all age groups.,
Revision: 5
Authorised
2017-06-02
34 _ _ B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE USER REFIXIA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION REFIXIA 1 000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION REFIXIA 2 000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION REFIXIA 3 000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION nonacog beta pegol 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 Refixia is and what it is used for 2. What you need to know before you use Refixia 3. How to use Refixia 4. Possible side effects 5. How to store Refixia 6. Contents of the pack and other information 1. WHAT REFIXIA IS AND WHAT IT IS USED FOR WHAT REFIXIA IS Refixia contains the active substance nonacog beta pegol. It is a long-acting version of factor IX. Factor IX is a protein naturally found in the blood that helps to stop bleeding. WHAT REFIXIA IS USED FOR Refixia is used to treat and prevent bleeding in all age groups of patients with haemophilia B (inborn factor IX deficiency). In patients with haemophilia B, factor IX is missing or does not work properly. Refixia replaces this faulty or missing factor IX and helps blood to form clots at the site of bleeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE REFIXIA DO NOT USE REFIXIA • if you are allergic to the active substance or any of the other ingredients of Прочитайте повний документ
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 Refixia 500 IU powder and solvent for solution for injection Refixia 1 000 IU powder and solvent for solution for injection Refixia 2 000 IU powder and solvent for solution for injection Refixia 3 000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Refixia 500 I U powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog beta pegol*. After reconstitution, 1 ml of Refixia contains approximately 125 IU nonacog beta pegol. Refixia 1 000 IU powder and solvent for solution for injection Each vial contains nominally 1 000 IU nonacog beta pegol*. After reconstitution, 1 ml of Refixia contains approximately 250 IU nonacog beta pegol. Refixia 2 000 IU powder and solvent for solution for injection Each vial contains nominally 2 000 IU nonacog beta pegol*. After reconstitution, 1 ml of Refixia contains approximately 500 IU nonacog beta pegol. Refixia 3 000 IU powder and solvent for solution for injection Each vial contains nominally 3 000 IU nonacog beta pegol*. After reconstitution, 1 ml of Refixia contains approximately 750 IU nonacog beta pegol. *recombinant human factor IX, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology, covalently conjugated to a 40 kDa polyethylene-glycol (PEG). The potency (IU) is determined using the European Pharmacopoeia one-stage clotting test. The specific activity of Refixia is approximately 144 IU/mg protein. Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) selectively attached to specific N-linked glycans in the rFIX activation peptide. Upon activation of Refixia, the activation peptide including the 40 kDa polye Прочитайте повний документ