국가: 몰타
언어: 영어
출처: Medicines Authority
HUMAN COAGULATION FACTOR IX
Octapharma (IP) Limited
B02BD04
HUMAN COAGULATION FACTOR IX
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HUMAN COAGULATION FACTOR IX 500 IU
POM
ANTIHEMORRHAGICS
Authorised
2010-04-05
_ _ _ _ _1/12 _ PACKAGE LEAFLET: INFORMATION FOR THE USER OCTANINE 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 OCTANINE is and what it is used for 2. What do you need to know before you use OCTANINE 3. How to use OCTANINE 4. Possible side effects 5. How to store OCTANINE 6. Contents of the pack and other information 1. WHAT OCTANINE IS AND WHAT IT IS USED FOR OCTANINE 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. OCTANINE 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. OCTANINE 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 DO YOU NEED TO KNOW BEFORE YOU USE OCTANINE DO NOT USE OCTANINE: • if you are allergic to human blood coagulation factor IX or any of the other ingredients of this medicine (listed in section 6). _ _ _ _ _2/12 _ • if you suffer from heparin-induced thrombocytopenia type II, which is a fall in the number of platelets in the blood after administration of heparin. Platelets are cells in the 전체 문서 읽기
_Page 1 of 14 _ _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT OCTANINE 500 IU , 500 IU powder and solvent for solution for injection OCTANINE 1000 IU , 1000 IU powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION • OCTANINE 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.). • OCTANINE 1000 IU is presented as a powder and solvent for solution for injection containing nominally 1000 IU human coagulation factor IX per vial. The product contains approximately 100 IU/ml human coagulation factor IX when reconstituted with 10 ml water for injections (Ph.Eur.). OCTANINE 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 OCTANINE is approximately 100 IU/mg protein. This medicinal product contains up to 3 mmol (or 69 mg) sodium for 1 vial OCTANINE 500 IU and up to 6 mmol (or 138 mg) sodium for 1 vial OCTANINE 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 _Page 2 of 14 _ _ _ Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. _Page 3 of 14 _ _ _ _Previously untreated patients _ The safety and efficacy of OCTANINE in previously untreated patients have not yet been established. 전체 문서 읽기