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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Baricol 1.05 g/ml Rectal Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Barium Sulphate 1.05 g/ml.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Rectal Suspension
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
‘Baricol’ is a radiopaque diagnostic agent for use in air double contrast X-ray visualisation of the lower gastro-
intestinal tract.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
‘Baricol’ is intended for rectal (enema) administration. The dosage administered will be dependent upon the patient and
the technique involved and will be determined from experience by the radiologist.
ADULTS: The volume administered will normally be about 600 ml.
CHILDREN: The quantity of ‘Baricol’ should be determined, from experience, by the physician and will be dependent on
the age and weight of the child.
ELDERLY: Radiological examinations in the elderly should be carried out with extreme care and the dosage determined
by the radiologist.
At the time of the examination the large bowel should be free of any residues that may interfere with the X-ray
examination.
4.3 CONTRAINDICATIONS
‘Baricol’ should not be used in patients with unclear abdomen with irritated peritoneum and known or suspected
perforation; postoperative suture insufficiency, intestinal fistulae with a passage to the mediastinum, pleural cavity or
peritoneal cavity; fresh injuries or chemical burns of the oesophageal-gastro-intestinal tract, ischemia of the intestinal
wall, necrotising enterocolitis and immediately before surgery of the gastro-intestinal tract.
It should not be used in patients with hypersensitivity to barium sulphate or to any of the excipients.
IRISH MEDICINES BOARD
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