Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Urokinase
Medac Gesellschaft fur Klinische Spezialpraparate mbH
B01AD; B01AD04
Urokinase
500,000 international unit(s)
Powder for solution for infusion
Product subject to prescription which may not be renewed (A)
Enzymes; urokinase
Not marketed
2016-04-29
Urokinase medac · 82100-VBIL · AA · 09.18 · Pharma-Code: 276 (Dummy) Format: 592 x 150 mm · Template: VP_592x150_V02 · HKS 44 · Corrective action: KV01_osc_08.08.17 / KV02_jem_16.05.18 / KV03_osc_08.06.18 / KV04_osc_27.09.18 / KV05_osc_02.10.18 PACKAGE LEAFLET: INFORMATION FOR THE USER UROKINASE MEDAC 10,000 IU, POWDER FOR SOLUTION FOR INFUSION UROKINASE MEDAC 50,000 IU, POWDER FOR SOLUTION FOR INFUSION UROKINASE MEDAC 100,000 IU, POWDER FOR SOLUTION FOR INFUSION UROKINASE MEDAC 250,000 IU, POWDER FOR SOLUTION FOR INFUSION UROKINASE MEDAC 500,000 IU, 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, pharmacist or nurse. • 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 Urokinase is and what it is used for 2. What you need to know before you use Urokinase 3. How to use Urokinase 4. Possible side effects 5. How to store Urokinase 6. Contents of the pack and other information 1. WHAT UROKINASE IS AND WHAT IT IS USED FOR Urokinase medac contains human urokinase extracted from human urine. Urokinase is an antithrombotic agent and is indicated for the 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, and 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. Urokinase is a powder for intravenous 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 IU per vial. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE UROKINASE Urokina Lue koko asiakirja
Health Products Regulatory Authority 13 November 2018 CRN008QS8 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Urokinase medac 500,000 IU, powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500,000 IU 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 Urokinase is indicated 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. Posology Dose and duration of administration depend on the respective indication. They may be adjusted individually depending on the clinical condition. The following dose regimens should be used as a guideline. Health Products Regulatory Authority 13 November 2018 CRN008QS8 Page 2 of 11 _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 through an intra-arterial catheter for the first 2 – 4 hours or until restoration of antegrade flow and 1,000 – 2,000 Lue koko asiakirja