Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Iopamidol
Bracco Imaging spa
V08AB; V08AB04
Iopamidol
340 milligram(s)
Solution for injection
Product subject to prescription which may not be renewed (A)
Watersoluble, nephrotropic, low osmolar X-ray contrast media; iopamidol
Marketed
1989-11-06
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 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 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 you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, see section 4. WHAT IS IN THIS LEAFLET : 1. What Niopam is and what it is used for 2. What you need to know before you are given Niopam 3. How you are given Niopam 4. Possible side effects 5. How to store Niopam 6. Contents of the pack and other information 1. WHAT IS NIOPAM 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. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NIOPAM YOU SHOULD NOT BE GIVEN NIOPAM IF YOU: • Are allergic to Iopamidol, or any other ingredients of this medicine (listed 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-active thyroid gland (this is particularly important in newborn babies) • A history of epilepsy • Myelomatosis (Cancer of the plasma cells in the blood) • Severe systemic disease (a disease affecting more than one part or organ of the body) • Sickle cell disease Lugege kogu dokumenti
Health Products Regulatory Authority 06 January 2023 CRN00CSK5 Page 1 of 9 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 the 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 This medicinal product is for diagnostic use only. 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. POSOLOGY 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: ** Selective visceral angiography Hepatic Coeliac Superior Mesenteric Inferior Mesenteric Adults: 30-70ml Adults: 40-70ml Adults: 25-70ml Adults: 5-30ml Health Products Regulatory Authority 06 January 2023 CRN00CSK5 Page 2 of 9 Digital subtraction angiography (DSA) Intravenous injection Coronary arteriography - by intra-arterial DSA, Ventriculography Adults: 30-50ml Children: ** Adults: 2-5ml Adults: 25ml* Children: 1.0-1.5ml/kg Computer Tomography enhancement Adults 50 - 100ml Intravenous Urography Adults: up to 1.5ml/kg Children: 1-.5ml/kg or ** Arthrography Adults 1-10ml according to the joint being examined. * repeat as necessary; ** according to body size and age; The dosage must be adapted Lugege kogu dokumenti