Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
IOPAMIDOL
Bracco UK Limited
300
Unknown
2001-04-10
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gastromiro 612.4 mg/ml oral or rectal solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 612.4mg iopamidol equivalent to 300mg iodine. Excipients: Ethanol 48.4 mg/20 ml, 121 mg/50 ml, and 242 mg/100 ml For full list 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 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: d) Meconium ileus equivalent. e) Intussusception. f) Colonic obstruction. g) 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. iii) 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. IRISH MEDICINES BOARD ______________________________________________________________________________________________ Läs hela dokumentet