Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BARIUM SULFATE
Bracco UK Limited
49.2 Mg/Ml
Cachet
2010-11-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BariCat 49.2 mg/ml concentrate for oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 225ml of undiluted suspension contains 11.07g of barium sulfate (49.2 mg/ml). Excipients : Each dose of 225 ml undiluted suspension contains 16 g sorbitol (E420) (as sorbitol, liquid (crystallising)). Each dose of 225 ml of undiluted suspension contains 110.25mg of methyl parahydroxybenzoate (E218). Each dose of 225 ml of undiluted suspension contains approximately 206 mg of sodium. Each dose of 225 ml of undiluted suspension contains approximately 50 mg of potassium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for oral suspension. A white viscous, aqueous suspension with a sweet orange flavour, without grittiness. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. BariCat should be used, following dilution as instructed, to opacify the gastro-intestinal tract prior to computerised axial tomography. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The concentrate is diluted with water to obtain a desired concentration. Recommended dilutions are shown in section 6.6. Adults including the elderly: 350 - 450 ml of diluted suspension 30 minutes prior to the scan and the same volume 5 minutes prior to the scan, or as directed by the physician. Children: The quantity of BariCat given should be determined, from experience, by the physician and will be dependent on the age and weight of the child. 4.3 CONTRAINDICATIONS _Immune System Disorders_ Hypersensitivity to barium sulfate or to any of the excipients. _Gastrointestinal Disorders_ IRISH MEDICINES BOARD _________________________________________________________________ Read the complete document