Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Albutrepenonacog alfa
CSL Behring UK Ltd
Albutrepenonacog alfa
500unit
Powder and solvent for solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5028360001111
PACKAGE LEAFLET: INFORMATION FOR THE USER IDELVION 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IDELVION 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IDELVION 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IDELVION 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Albutrepenonacog alfa P 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 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 IDELVION is and what it is used for 2. What you need to know before you use IDELVION 3. How to use IDELVION 4. Possible side effects 5. How to store IDELVION 6. Contents of the pack and other information 1. WHAT IDELVION IS AND WHAT IT IS USED FOR WHAT IS IDELVION? IDELVION is a haemophilia medicine that replaces a natural blood clotting (coagulation) factor IX. The active substance in IDELVION is albutrepenonacog alfa (recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)). Factor IX is involved in blood clotting. Patients with haemophilia B have a lack of this factor which means that their blood does not clot as quickly as it should so there is an increased tendency to bleed. IDELVION works by replacing factor IX in haemophilia B patients to enable their blood to clot. WHAT IS IDELVION USED FOR? IDELVION is used to prevent or to halt bleeding caused by the lack of factor Baca dokumen lengkapnya
OBJECT 1 IDELVION 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Summary of Product Characteristics Updated 31-Jan-2018 | CSL Behring UK Limited 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 IDELVION ® 250 IU powder and solvent for solution for injection IDELVION ® 500 IU powder and solvent for solution for injection IDELVION ® 1000 IU powder and solvent for solution for injection IDELVION ® 2000 IU powder and solvent for solution for injection 2. Qualitative and quantitative composition IDELVION 250 IU powder and solvent for solution for injection One vial contains nominally 250 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa). After reconstitution with 2.5 ml water for injections the solution contains 100 IU/ml of albutrepenonacog alfa. IDELVION 500 IU powder and solvent for solution for injection One vial contains nominally 500 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa). After reconstitution with 2.5 ml water for injections the solution contains 200 IU/ml of albutrepenonacog alfa. IDELVION 1000 IU powder and solvent for solution for injection One vial contains nominally 1000 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa). After reconstitution with 2.5 ml water for injections the solution contains 400 IU/ml of albutrepenonacog alfa. IDELVION 2000 IU powder and solvent for solution for injection One vial contains nominally 2000 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa). After reconstitution with 5 ml water for injections the solution contains 400 IU/ml of albutrepenonacog alfa. The pote Baca dokumen lengkapnya