Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
UROKINASE (PURIFIED BULK)
Fannin Limited
B01AD04
UROKINASE (PURIFIED BULK)
500,000 International Unit
Pdr for Soln for Infusion
Product subject to prescription which may not be renewed (A)
UROKINASE
Authorised
2016-04-29
PACKAGE LEAFLET: INFORMATION FOR THE USER UROKINASE FANNIN 10,000 I.U. UROKINASE FANNIN 50,000 I.U. UROKINASE FANNIN 100,000 I.U. UROKINASE FANNIN 250,000 I.U. UROKINASE FANNIN 500,000 I.U. POWDER FOR SOLUTION FOR INFUSION [Urokinase] 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. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Urokinase is and what it is used for 2. What you need to know before use of Urokinase 3. How to use Urokinase 4. Possible side effects 5. How to store Urokinase 6. Further information 1 WHAT UROKINASE IS AND WHAT IT IS USED FOR Urokinase is a powder for IV infusion (administration into the veins). Strength of urokinase is given in international units (IU). Urokinase contains 10,000, 50,000, 100,000, 250,000 or 500,000 I.U. per vial. Urokinase is an antithrombotic agent which is a preparation that is able to dissolve blood clots. Urokinase is indicated for treatment of acute occlusions of blood vessels caused by blood clots such as: peripheral vascular occlusion, i.e. blood clots blocking the blood vessel system of the extremities. Severe pulmonary embolism, i.e blood clots in lungs In addition, Urokinase can be used to dissolve blood clots that develop in shunts of dialysis patients. 2 WHAT YOU NEED TO KNOW BEFORE USE OF UROKINASE Urokinase is used by doctors in hospitals who have experience in the treatment of thrombosis disorders. Your general state of health and medical history, including previously or currently used medicines, will be carefully assessed before the treatment with Urokinase is c Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Urokinase Fannin 500,000 I.U., powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500,000 I.U. of human urokinase extracted from human urine For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White, powder for solution for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of acute vascular occlusions caused by thrombosis or embolism such as: - acute occlusive peripheral arterial disease with limb threatening ischaemia. - Severe Pulmonary embolism. - Haemodialysis shunts blocked by fibrin clots. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Urokinase should only be used by physicians experienced in the management of thromboembolic diseases in hospitals where adequate diagnostic and monitoring techniques are available. Before starting thrombolytic therapy with urokinase, haemostasis tests should be performed including haematocrit, platelet count, thrombin time (TT) and activated partial thromboplastin time (aPTT). If heparin has been given, it should be discontinued and the aPTT should be less than twice the normal control value before urokinase therapy is initiated. After reconstitution, the solution should be clear and colourless. POSOLOGY ADULTS Dosage and duration of administration depend on the respective indication. It may be adjusted individually depending on the clinical condition. The following dose regimens should be used as a guideline. _ACUTE OCCLUSIVE PERIPHERAL ARTERIAL DISEASE WITH LIMB THREATENING ISCHAEMIA_ Various regimens have been described in the literature, but none has been proven to be superior. However, catheter- directed local lysis is the preferred method of administration. 4,000 IU/min (240,000 IU/h) is infused Read the complete document