GASTROMIRO 612.4 MG/ML ORAL OR RECTAL SOLUTION.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
IOPAMIDOL
Available from:
Bracco UK Limited
Dosage:
300
Pharmaceutical form:
Unknown
Authorization date:
2001-04-10
Summary of Product characteristics
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
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