Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
HUMAN COAGULATION FACTOR II, HUMAN COAGULATION FACTOR VII, HUMAN COAGULATION FACTOR IX, HUMAN COAGULATION FACTOR X, PROTEIN C, PROTEIN S
Octapharma Limited
B02BD01
HUMAN COAGULATION FACTOR II, HUMAN COAGULATION FACTOR VII, HUMAN COAGULATION FACTOR IX, HUMAN COAGULATION FACTOR X, PROTEIN C, P
1000 International Unit
Pdr+Solv for soln for Inf
Product subject to prescription which may not be renewed (A)
Blood coagulation factors
Authorised
2015-11-13
PACKAGE LEAFLET: INFORMATION FOR THE USER OCTAPLEX 500 IU coagulation factor IX per vial, powder and solvent for solution for infusion – Human prothrombin complex OCTAPLEX 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusion – Human prothrombin complex 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 Octaplex is and what it is used for 2. What do you need to know before you use Octaplex 3. How to use Octaplex 4. Possible side effects 5. How to store Octaplex 6. Contents of the pack and other information 1. WHAT OCTAPLEX IS AND WHAT IT IS USED FOR Octaplex belongs to a group of medicines called clotting factors. It contains the human vitamin K dependent blood coagulation factors II, VII, IX and X. Octaplex is used to treat and prevent bleeding: • caused by medicines called vitamin K antagonists (such as warfarin). These medicines block the effect of vitamin K and cause a shortage of the vitamin K dependent clotting factors in your body. Octaplex is used when rapid correction of the shortage is required. • in people born with a shortage of the vitamin K dependent clotting factors II and X. It is used when purified specific clotting factor product is not available. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OCTAPLEX OCTAPLEX MUST NOT BE USED: • if you are allergic to one of the ingredients of this product (listed in section 6). • if you are allergic to heparin or if heparin has ever caused a reduction in the level of platelets in your bl Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Octaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusion Human Prothrombin Complex 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Octaplex is presented as a powder and solvent for solution for infusion containing human prothrombin complex. Octaplex nominally contains: The total protein content per vial is 520 - 1640 mg. The specific activity of the product is 0.6 IU/mg proteins, expressed as factor IX activity. Excipients known to have a recognised action or effect: sodium (150 - 250 mg per vial), heparin (200 - 500 IU per vial, corresponding to 0.2 - 0.5 IU/IU FIX)). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for infusion. The powder is of bluish-white colour. The solvent is a clear and colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required. - Treatment of bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent coagulation factors II and X when purified specific coagulation factor product is not available. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY NAME OF INGREDIENT OCTAPLEX QUANTITY PER VIAL (IU) OCTAPLEX QUANTITY AFTER RECONSTITUTION WITH 40 ML OF WATER FOR INJECTIONS (IU/ML) _Active substances_ Human coagulation factor II 560 -1520 14 - 38 Human coagulation factor VII 360 – 960 9 - 24 Human coagulation factor IX 1000 25 Human coagulation factor X 720 - 1200 18 - 30 _Further active ingredients_ Protein C 520 - 1240 13 - 31 Protein S 480 - 1280 12 - 32 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lestu allt skjalið