Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
FACTOR IX, HUMAN
Octapharma Limited
B02BD04
FACTOR IX, HUMAN
500 International Unit
Pdr+Solv for Soln for Inj
Product subject to prescription which may not be renewed (A)
Blood coagulation factors
Authorised
2010-10-15
_2169892.PA0521_018_001.fc177e20-e057-4dbe-a1a9-1962d7ec733a_13_.20151010_PIL_230_IE_03.02.160216 _ _ 1/12 _ PACKAGE LEAFLET: INFORMATION FOR THE USER NANOFIX 500 IU / 1000 IU, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION HUMAN COAGULATION FACTOR IX 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 NanoFIX is and what it is used for 2. What you need to know before you use NanoFIX 3. How to use NanoFIX 4. Possible side effects 5. How to store NanoFIX 6. Contents of the pack and other information 1. WHAT NANOFIX IS AND WHAT IT IS USED FOR NanoFIX belongs to a group of medicines called clotting factors and contains the human blood coagulation factor IX. This is a special protein, which increases the ability of the blood to clot. NanoFIX is used for the treatment and prevention of bleeding in patients with bleeding disorder (haemophilia B). This is a medical condition in which bleeding can go on for longer than expected. It is due to an in-born deficiency in the amount of coagulation factor IX in the blood. NanoFIX is supplied as a powder and solvent to prepare a solution for injection. After reconstitution, it is administered intravenously (injected into a vein). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NANOFIX DO NOT USE NANOFIX: • if you are allergic to huma Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NanoFix 500 IU, 500 IU powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NanoFix 500 IU is presented as a powder and solvent for solution for injection containing nominally 500 IU human coagulation factor IX per vial. The product contains approximately 100 IU/ml human coagulation factor IX when reconstituted with 5 ml water for injections (Ph.Eur.). NanoFix is produced from plasma of human donors. The potency (IU) is determined using the European Pharmacopoeia one stage clotting test, in comparison with an international standard from the World Health Organisation (WHO). The specific activity of NanoFix is approximately 100 IU/mg protein. This medicinal product contains up to 3 mmol (or 69 mg) sodium for 1 vial NanoFix 500 IU and up to 6 mmol (or 138 mg) sodium for 1 vial NanoFix 1000 IU per dose. To be taken into consideration by patients on a controlled sodium diet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white or pale yellow also appearing as a friable solid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. _Previously untreated patients_ The safety and efficacy of NanoFix in previously untreated patients have not yet been established. Treatment monitoring During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infus Prečítajte si celý dokument