Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Iopromide
Bayer Limited
V08AB; V08AB05
Iopromide
370 milligram(s)/millilitre
Solution for injection
Product subject to Restricted Prescription (C)
Watersoluble, nephrotropic, low osmolar X-ray contrast media; iopromide
Not marketed
1986-09-24
20084 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ULTRAVIST® 240 mg/ml Solution for injection ULTRAVIST® 300 mg/ml Solution for injection ULTRAVIST® 370 mg/ml Solution for injection iopromide 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 the doctor giving you Ultravist (the radiologist) or the X-ray department staff If you get any side effects, talk to your doctor or the X-ray department staff/radiologist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT ULTRAVIST IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ULTRAVIST 3. HOW YOU WILL BE GIVEN ULTRAVIST 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ULTRAVIST 6. CONTENTS OF THE PACK AND OTHER INFORMATION 7. INFORMATION FOR HEALTHCARE PROFESSIONALS ONLY 1. WHAT ULTRAVIST IS AND WHAT IT IS USED FOR Ultravist is an injectable contrast medium (a dye) which contains iodine. It is used to clearly show in X-rays the area of your body that your doctor wants to investigate. X-rays, like radio waves, can pass through objects and can be focused to make a picture. When you have an X-ray, the beam of rays goes through your body where it is absorbed to differing degrees by different tissues such as bones, muscles and organs. When the rays come out on the other side they make a pattern of light and shade on a film. Ultravist helps to make this pattern clearer. The film is then examined by a specialist who will make a diagnosis. This medicine is for diagnostic use only. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ULTRAVIST DO NOT USE ULTRAVIST: if you are allergic to iodine or iodine containing contrast media or any of the other ingredients of this medicine (listed in Section 6) if you have a condition caused by too much thyroid hormone (uncontrolled thyrotoxicosis). WARNINGS AND PRECAUTIONS You must tell Read the complete document
Health Products Regulatory Authority 14 October 2020 CRN009Z6T Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ultravist 370mg/ml Solution for Injection (50 ml, 100ml, 150 ml, and 200 ml) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ultravist 370: 1ml contains 769 mg iopromide, equivalent to 370 mg iodine. This medicinal product contains 12.3 micrograms sodium per ml. For a full list of excipients, _see Section 6.1._ 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless to pale yellow aqueous solution. The physico-chemical properties of Ultravist at the concentrations listed below are: Iodine concentration (mg/ml) 240 300 370 Osmolality (osm/kg H 2 O) at 37 °C Viscosity (mPa.s) at 20 °C at 37 °C 0.48 4.9 2.8 0.59 8.9 4.7 0.77 22.0 10.0 Density (g/ml) at 20 °C at 37 °C 1.263 1.255 1.328 1.322 1.409 1.399 pH-value 6.5-8.0 6.5-8.0 6.5-8.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Ultravist 370: For intravascular use and use in body cavities. Contrast enhancement in computerised tomography (CT), digital subtraction angiography (DSA), intravenous urography, arteriography and especially angiocardiography, visualisation of body cavities (e.g. arthrography, fistulography) with the exception of myelography, ventriculography, cisternography. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GENERAL INFORMATION WARNING PRIOR TO USE Contrast media which are warmed to body temperature before administration are better tolerated and can be injected more easily because of reduced viscosity. Health Products Regulatory Authority 14 October 2020 CRN009Z6T Page 2 of 12 For additional instructions see section 6.6. Posology and method of administration DOSAGE FOR INTRAVASCULAR USE In patients suffering from marked renal or cardiovascular insufficiency and in patients in a poor general condition, the contrast medium dose must be kept as low as possible. In these patients it is advisable to monitor renal function in accordance with the clinic Read the complete document