Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
BARIUM SULFATE
Bracco UK Limited
98.45%w/w %w/w
Powder for Oral Suspension
2010-05-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Maxibar 98.45% w/w powder for oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Barium sulfate 98.45% w/w Also contains sorbitol (E420), 2 g per 340 g dose; and approx. 310 mg sodium per 340 g dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. A white to off-white bulky powder for oral suspension with a slightly sweet fruit taste and some grittiness, intended for suspension in water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. 'Maxibar' is 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 Maxibar is recommended for oral administration. The powder must be reconstituted prior to administration (see section 6.6). The administered dose of Maxibar will depend on the patient in question and the section of the gastrointestinal tract to be viewed. ADULTS: Instructions for reconstitution are shown in section 6.6 but the actual administered dose should be determined, from experience, by the radiologist. ELDERLY: The dosage should be determined, from experience, by the radiologist. There are no special dosage recommendations. CHILDREN: The dosage will be dependent on the size, age, health state and anatomic region to be imaged of the child. Individual requirements should be determined, from experience, by the radiologist. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/10/2010_ _CRN 2090638_ _page number: 1_ 4.3 CONTRAINDICATION Läs hela dokumentet