מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Human plasma coagulation factor ii; Human plasma coagulation factor vii; Human plasma coagulation factor ix; Human plasma coagulation factor x; Protein c; Protein s
Octapharma (IP) SPRL
B02BD; B02BD01
Human plasma coagulation factor ii; Human plasma coagulation factor vii; Human plasma coagulation factor ix; Human plasma coagulation factor x; Protein c; Protein s
500 international unit(s)
Powder and solvent for solution for infusion
Product subject to prescription which may not be renewed (A)
Blood coagulation factors; coagulation factor IX, II, VII and X in combination
Marketed
2004-07-02
_ _ _ _ _1/8_ 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 y קרא את המסמך השלם
Health Products Regulatory Authority 29 January 2021 CRN00C4QX Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman 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: NAME OF INGREDIENT OCTAPLEX Quantity per vial (IU) OCTAPLEX QUANTITY AFTER RECONSTITUTION WITH 20 ML OF WATER FOR INJECTIONS (IU/ML) _Active substances_ Human coagulation factor II 280 - 760 14 - 38 Human coagulation factor VII 180 - 480 9 - 24 Human coagulation factor IX 500 25 Human coagulation factor X 360 - 600 18 - 30 _Further active ingredients_ Protein C 260 - 620 13 - 31 Protein S 240 - 640 12 - 32 The total protein content per vial is 260 - 820 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 (75 - 125 mg per vial), heparin (100 - 250 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. Health Products Regulatory Authority 29 January 2021 CRN00C4QX Page 2 of 10 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Only קרא את המסמך השלם