국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Eftrenonacog alfa
Swedish Orphan Biovitrum Ltd
Eftrenonacog alfa
500unit
Powder and solvent for solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 7350031441031
1 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 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, 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 c 전체 문서 읽기
OBJECT 1 ALPROLIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Summary of Product Characteristics Updated 06-Jul-2017 | Swedish Orphan Biovitrum Ltd 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 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 eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 50 IU eftrenonacog alfa. ALPROLIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 100 IU eftrenonacog alfa. ALPROLIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 200 IU eftrenonacog alfa. ALPROLIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 400 IU eftrenonacog alfa. ALPROLIX 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 600 IU eftrenonacog alfa. The potency (International Units) is determined using the European Pharmacopoeia one stage clotting test against an in-house standard that 전체 문서 읽기