Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nonacog alfa
Pfizer Ltd
B02BD04
Nonacog alfa
250unit
Powder and solvent for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02110000; GTIN: 5013457021851
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER BENEFIX 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION BENEFIX 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION BENEFIX 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION BENEFIX 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION BENEFIX 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION BENEFIX 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Nonacog alfa (recombinant coagulation factor IX) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 BeneFIX is and what it is used for 2. What you need to know before you take BeneFIX 3. How to take BeneFIX 4. Possible side effects 5. How to store BeneFIX 6. Contents of the pack and other information 1. WHAT BENEFIX IS AND WHAT IT IS USED FOR BeneFIX is an injectable clotting (coagulation) factor IX product that is produced by recombinant DNA technology. The active ingredient in BeneFIX is nonacog alfa. People who are born with haemophilia B (Christmas disease) lack sufficient factor IX to control bleeding. BeneFIX works by replacing factor IX in haemophilia B patients to enable their blood to clot. BeneFIX is used for the treatment and prevention of bleeding in patients with haemophilia B (congenital factor IX deficiency) in all age groups. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENEFIX DO NOT TAKE BENEFIX: - If you are allergic to nonacog alfa or any of the other ingredients of this medicine (listed in section 6). - If you are allergic to hamster proteins. WARNINGS Read the complete document
OBJECT 1 BENEFIX Summary of Product Characteristics Updated 10-Jul-2017 | Pfizer Limited 1. Name of the medicinal product BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection 2. Qualitative and quantitative composition BeneFIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 50 IU nonacog alfa. BeneFIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 100 IU nonacog alfa. BeneFIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 200 IU nonacog alfa. BeneFIX 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 300 IU nonacog alfa. BeneFIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the Read the complete document