Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
IOPAMIDOL
Bracco UK Limited
IOPAMIDOL
340 Milligram
Solution for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER NIOPAM 340 SOLUTION FOR INJECTION (Iopamidol) The name of your medicine is Niopam 340 solution for injection, which will be called Niopam throughout this leaflet READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Niopam is and what it is used for 2. Before you are given Niopam 3. How you are given Niopam 4. Possible side effects 5. How to store Niopam 6. Further information 1. WHAT NIOPAM IS AND WHAT IT IS USED FOR Niopam is a special dye (or contrast agent) which blocks X-rays because it contains iodine. Niopam works by helping your doctor to see the internal body structures on an X-ray picture. Your doctor has prescribed Niopam to help view the blood vessels, kidney, bladder or joints using X-rays. This medicine is for diagnostic use only. 2. BEFORE YOU ARE GIVEN NIOPAM YOU SHOULD NOT BE GIVEN NIOPAM IF YOU: • Are allergic (hypersensitive) to Niopam, or other contrast media that contain iodine, • Are allergic to any other ingredients of Niopam (see list of ingredients in Section 6). TAKE SPECIAL CARE WITH NIOPAM AND TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING CONDITIONS: • A history of allergy or asthma • Diabetes • Heart problems • High blood pressure in the lungs • Kidney or liver problems • Over-act Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Niopam 340, Solution for Injection, glass bottles 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The solution contains 69.4% w/v Iopamidol equivalent to 340mg iodine/ml. Each ml contains 694 mg of Iopamidol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS X -ray contrast medium for use in peripheral arteriography, angiocardiography and left ventriculography, coronary arteriography, aortography, selective renal arteriography, selective visceral angiography, digital subtraction angiography, computer tomography enhancement, urography and arthrography. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Intravenous Intra-arterial Intraventricular or in Arthrography by injection. DOSAGE NIOPAM 340 : DOSAGE SCHEDULE Procedure Dosage Peripheral arteriography Adults: 10-50ml* Children: ** Angiocardiography and left ventriculography Adults: 30-80ml Children: ** Coronary arteriography Adults: 4-8ml per artery Aortography - retrograde Adults: 30-80ml Selective renal arteriography. Adults: 5-10ml Children: ** IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/06/2013_ _CRN 2108858_ _page number: 1_ * repeat as necessary; ** according to body size and age; The dosage must be adapted to the examination, the age, body weight, cardiac output, renal function, general condition of the patient and the technique used. Usually the same iodine concentration and volume are used with other iodinated x-ray contrast in current. As with all contrast media, the lowest dose necessary to obtain adequate visualisation should be used. Non -ionic contrast media have less a Lestu allt skjalið