Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
IOPAMIDOL
Bracco UK Limited
IOPAMIDOL
370 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 370 SOLUTION FOR INJECTION (Iopamidol) The name of your medicine is Niopam 370 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, urinary tract or bladder 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 • Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Niopam 370, Solution for Injection, glass bottles 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The solution contains 75.5% w/v Iopamidol, equivalent to 370 mg Iodine/ml. Each ml contains 755mg 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 on angiography, left ventriculography and coronary arteriography and urography. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Intraventricular Intra-arterial Intravenous. Dosage NIOPAM 370 : DOSAGE SCHEDULE Procedure Dosage Peripheral arteriography Venography Adults 10 - 50ml* Children * * Adults 20 - 50ml Children * * Angiocardiography and left ventriculography Adults 30 - 80ml Children * * Coronary arteriography Adults 4 - 8ml per artery Aortography - retrograde Adults 30 - 80ml Children * * IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/06/2013_ _CRN 2108858_ _page number: 1_ * Repeat as necessary * * According to body size and age Elderly: Dosage as for adults. 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 anti-coagulant activity _in_ -_vitro _than ionic media. Meticulous attention should therefore be paid to angiographic technique. Non -ionic media should not be allowed to remain Read the complete document