Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Iopamidol
Bracco Imaging spa
V08AB; V08AB04
Iopamidol
612.4 milligram(s)/millilitre
Oral/rectal solution
Product subject to prescription which may not be renewed (A)
Watersoluble, nephrotropic, low osmolar X-ray contrast media; iopamidol
Marketed
1990-04-10
PACKAGE LEAFLET: INFORMATION FOR THE USER GASTROMIRO 612.4MG/ML ORAL OR RECTAL SOLUTION IOPAMIDOL 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 - 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. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Gastromiro is and what it is used for 2. What you need to know before you use Gastromiro 3. How to use Gastromiro 4. Possible side effects 5. How to store Gastromiro 6. Contents of the pack and information 1. WHAT GASTROMIRO IS AND WHAT IT IS USED FOR Gastromiro is an X-ray contrast medium. This is a special dye which is opaque to X-rays because it contains iodine. X-ray radiation is used to obtain an image of the tissues of the body. The rays are directed on to the area of the body being investigated and pass through it to record an image on photographic film. If the doctor needs to highlight a particular area of the body to get better information, he/she will carry out a contrast X-ray. This means that a dye which absorbs X-rays will be used. Gastromiro is such a dye. It has been specially made into a drink or given as enema for investigation of the digestive system. Because of its special formulation Gastromiro is used particularly in situations where it is possible that some dye could leak outside the digestive system. It is also particularly suited to babies and children. Gastromiro may also be used if you are having a CAT scan (Computer Axial Tomography). This medicine is for diagnostic use only. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GASTROMIRO Gastromiro should only be given to you in a hospital or clinic where there are equipment and medically trained staff able to deal with allergic reactio Lees het volledige document
Health Products Regulatory Authority 22 January 2021 CRN009RRT Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gastromiro 612.4mg/ml oral or rectal solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 612.4mg iopamidol equivalent to 300mg iodine. Excipients with known effect: sodium 0.225 mg/ml (sodium cyclamate, disodium edetate dihydrate, sodium saccharinate), ethanol 2.42 mg/ml (orange and Red CuraVao flavours) For full lists of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral or rectal solution. A clear, particle-free solution with an orange odour and flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. All forms of radiological investigations of gastrointestinal tract, in particular:- 1. Paediatric radiology of the gastro-intestinal tract (GIT) where there is the possibility of: i. Spill into the respiratory tract, for example in: a) swallowing disorders b) oesophageal obstruction with a foreign body, atresia or stricture c) tracheo-oesophageal fistula. ii. Spill into the mediastinum, pleura, peritoneum or retroperitoneal tissues, for example due to perforation of the GIT. iii. Inspissation of fluid, for example in: a) Meconium ileus equivalent. b) Intussusception. c) Colonic obstruction. d) Hirschsprung’s disease. 2. Adult radiology of the gastro-intestinal tract, such as: i. Suspected upper gastro-intestinal perforation for example in: Oesophagogastrectomy, endoscopy, partial gastrectomy, pneumonectomy, ingestion of foreign body, duodenal ulceration, small bowel resection, Whipples procedure and blunt abdominal trauma. Health Products Regulatory Authority 22 January 2021 CRN009RRT Page 2 of 7 ii. Computer Tomography (CT) of the abdominal and pelvic regions, for example: a) Suspicion of expanding lesions of pancreas, liver and gall bladder. b) Space occupying metastatic lesions originating from prostate or recto-sigmoidal region in post-surgical staging of cancer. 4.2 POSOLOGY AND ME Lees het volledige document