Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
HUMAN COAGULATION FACTOR VIII
Octapharma Limited
B02BD02
HUMAN COAGULATION FACTOR VIII
1000 International Unit
Pdr+Solv for Soln for Inj
Product subject to prescription which may not be renewed (A)
Blood coagulation factors
Authorised
2014-11-28
PACKAGE LEAFLET: INFORMATION FOR THE USER OCTANATE LV 100 IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION HUMAN COAGULATION FACTOR VIII OCTANATE LV 200 IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION HUMAN COAGULATION FACTOR VIII 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 Octanate LV is and what it is used for 2. What do you need to know before you use Octanate LV 3. How to use Octanate LV 4. Possible side effects 5. How to store Octanate LV 6. Contents of the pack and other information 1. WHAT OCTANATE LV IS AND WHAT IT IS USED FOR Octanate LV belongs to a group of medicines called clotting factors and contains human blood coagulation factor VIII. This is a special protein involved in blood clotting. Octanate LV is used to treat and prevent bleeding in patients with haemophilia A. This is a condition in which bleeding can go on for longer than expected. It is due to an hereditary lack of coagulation factor VIII in the blood. 2. WHAT DO YOU NEED TO KNOW BEFORE YOU USE OCTANATE LV It is strongly recommended that every time you receive a dose of Octanate LV the name and batch number of the product are recorded in order to maintain a record of the batches used. Your doctor may recomme Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Octanate 1000 IU powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Octanate 200 IU/ml contains nominally 1000 IU human coagulation factor VIII per vial. The product contains approximately 200 IU* per ml human coagulation factor VIII when reconstituted with 5 ml of solvent. Produced from the plasma of human donors. The product contains approximately 120 IU per ml von Willebrand factor (VWF:RCo). Excipient with known effect: Sodium up to 1.75 mmol (40 mg) per dose Sodium concentration after reconstitution: 250 – 350 mmol/l For the full list of excipients, see section 6.1. * The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The mean specific activity of Octanate is 100 IU/mg protein. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white or pale yellow also appearing as a friable solid. The solvent is a clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand’s disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. POSOLOGY The dosage and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding, and on the patient’s clinical condition. The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current Прочетете целия документ