দেশ: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
BARIUM SULFATE
PROMEDICO LTD
V08BA02
POWDER FOR SUSPENSION
BARIUM SULFATE 98.3845 %W/W
PER OS
Required
E-Z-EM INC., USA
BARIUM SULFATE WITHOUT SUSPENDING AGENTS
BARIUM SULFATE WITHOUT SUSPENDING AGENTS
For double contrast radiography of the oesophagus, stomach and duodenum.
2010-09-30
E-Z-HD 98 % W/W POWDER FOR ORAL SUSPENSION 1 NAME OF THE MEDICINAL PRODUCT E-Z-HD 98 % w/w powder for oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _Active Constituent: _ _ _ _ _ _ _ _ _ _ _ Barium sulfate 98.45 % w/w _Excipients include: _ Sorbitol (E420), 2 g per 340 g dose. Approximately 310 mg sodium per 340 g dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. White powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. E-Z-HD is a high density suspension for use as a radiopaque agent during X-ray visualisation of the upper gastro-intestinal tract (oesophagus, stomach and duodenum). It is designed for optimal use in double contrast X-ray examinations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION E-Z-HD must be administered orally. The powder must be reconstituted prior to administration (see section 6.6). The administered dose of E-Z-HD will depend on the patient in question and the section of the gastrointestinal tract to be viewed. ADULTS: The contents of one prefilled bottle (340 g) are dispersed in 65 mL of water to produce a 250 % w/v suspension which is swallowed by the patient after a suitable gas producing agent has been administered. CHILDREN: The dosage will be dependent on the size, age, health state and anatomical region to be imaged of the child. Individual requirements should be determined, from experience, by the radiologist. ELDERLY: There are no special dosage recommendations. The dosage should be determined, from experience, by the radiologist. 4.3 CONTRAINDICATIONS _Immune System Disorders _ Hypersensitivity to barium sulfate or to any of the excipients. _Gastrointestinal Disorders _ Patients with any of the following: – a known or suspected fistula, perforation or obstruction in any part of the gastrointestinal tract – gastrointestinal haemorrhage – gastrointestinal ischemia – megacolon or toxic megacolon – necrotising entercolitis – severe constipation – সম্পূর্ণ নথি পড়ুন