Država: Armenija
Jezik: angleščina
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
human blood coagulation factor VIII
Octapharma Pharmazeutika Produktionsges. m.b.H.
human blood coagulation factor VIII
1000IU/vial
powder lyophilized for solution for injection
Prescription
_Octanate 1.12.14.doc _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _1/10 _ PACKAGE LEAFLET: INFORMATION FOR THE USER OCTANATE 50 IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION HUMAN COAGULATION FACTOR VIII OCTANATE 100 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. • Please keep this leaflet. You may need to read it again. • If you have further questions, please 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. WHAT IS IN THIS LEAFLET 1. What Octanate is and what it is used for 2. What do you need to know before you use Octanate 3. How to use Octanate 4. Possible side effects 5. How to store Octanate 6. Contents of the pack and other information 1. WHAT OCTANATE IS AND WHAT IT IS USED FOR Octanate 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 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 • It is strongly recommended that every time you receive a dose of Octanate the name and batch number of the product are recorded in order to maintain a record of the batches used. • Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly or repeatedly receive human-derived Factor VIII products. _Octanate 1.12.14.doc _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _2/10 _ DO NOT USE OCTANATE • if you are allergic to human blood coag Preberite celoten dokument
_20141028_spc_120_AM_03.02_en.doc_ _ _ 1/8 INSTRUCTION FOR USE (Summary of Product Characteristics) 1 NAME OF THE MEDICINAL PRODUCT OCTANATE 250, 250 IU powder and solvent for solution for injection OCTANATE 500, 500 IU powder and solvent for solution for injection OCTANATE 1000, 1000 IU powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OCTANATE 250 IU is presented as powder and solvent for solution for injection containing nominally 250 IU human coagulation factor VIII per vial. The product contains approximately 50 IU* per ml human coagulation factor VIII when reconstituted with 5 ml of solvent. The product contains approximately ≤ 30 IU per ml von Willebrand factor (VWF:RCo). OCTANATE 500 IU is presented as powder and solvent for solution for injection containing nominally 500 IU human coagulation factor VIII per vial. The product contains approximately 50 IU* per ml human coagulation factor VIII when reconstituted with 10 ml of solvent. The product contains approximately ≤ 30 IU per ml von Willebrand factor (VWF:RCo). OCTANATE 1000 IU is presented as powder and solvent for solution for injection containing nominally 1000 IU human coagulation factor VIII per vial. The product contains approximately 100 IU* per ml human coagulation factor VIII when reconstituted with 10 ml of solvent. The product contains approximately ≤ 60 IU per ml von Willebrand factor (VWF:RCo) This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially `sodium- free` for 1 vial OCTANATE 250 IU and up to 1.75 mmol sodium (40 mg) per dose for 1 vial OCTANATE 500 IU and 1000 IU, respectively. To be taken into consideration by patients on a controlled sodium diet. For a 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. A white or pale yellow powder or friable sol Preberite celoten dokument