Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
eftrenonacog alfa
Swedish Orphan Biovitrum AB (publ)
B02BD04
eftrenonacog alfa
Vitamin K and other hemostatics, Blood coagulation factors
Hemophilia B
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Revision: 8
Authorised
2016-05-12
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER ALPROLIX 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ALPROLIX 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ALPROLIX 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ALPROLIX 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ALPROLIX 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION eftrenonacog alfa (recombinant coagulation factor IX, Fc fusion protein) 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What ALPROLIX is and what it is used for 2. What you need to know before you use ALPROLIX 3. How to use ALPROLIX 4. Possible side effects 5. How to store ALPROLIX 6. Contents of the pack and other information 7. Instructions for preparation and administration 1. WHAT ALPROLIX IS AND WHAT IT IS USED FOR ALPROLIX contains the active substance eftrenonacog alfa, recombinant coagulation factor IX, Fc fusion protein. Factor IX is a protein produced naturally in the body necessary for the blood to form clots and stop bleeding. ALPROLIX is a medicine used for the treatment and prevention of bleeding in all age groups of patients with haemophilia B (inherited bleeding disorder caused by factor IX deficiency). ALPROLIX is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process. HOW ALPROLIX WORKS In patients with haemophilia B, factor IX is missing or not working properly. This medicine is used to replace the missing or deficient factor I Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ALPROLIX 250 IU powder and solvent for solution for injection ALPROLIX 500 IU powder and solvent for solution for injection ALPROLIX 1000 IU powder and solvent for solution for injection ALPROLIX 2000 IU powder and solvent for solution for injection ALPROLIX 3000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ALPROLIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor IX (rDNA), eftrenonacog alfa. ALPROLIX contains approximately 250 IU (50 IU/mL) of human coagulation factor IX (rDNA), eftrenonacog alfa after reconstitution. ALPROLIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor IX (rDNA), eftrenonacog alfa. ALPROLIX contains approximately 500 IU (100 IU/mL) of human coagulation factor IX (rDNA), eftrenonacog alfa after reconstitution. ALPROLIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor IX (rDNA), eftrenonacog alfa. ALPROLIX contains approximately 1000 IU (200 IU/mL) of human coagulation factor IX (rDNA), eftrenonacog alfa after reconstitution. ALPROLIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor IX (rDNA), eftrenonacog alfa. ALPROLIX contains approximately 2000 IU (400 IU/mL) of human coagulation factor IX (rDNA), eftrenonacog alfa after reconstitution. ALPROLIX 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor IX (rDNA), eftrenonacog alfa. ALPROLIX contains approximately 3000 IU (600 IU/mL) of human coagulation factor IX (rDNA), eftrenonacog alfa after reconstitution. The potency (IU) is determined using the European Pharmacopoeia one stage clotting test. The specific activity of ALPROLIX is 55-84 IU/mg protein. Eftrenonacog alfa (recombinant human coag Læs hele dokumentet