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HSA Product

GASTROGRAFIN SOLUTION

Product approved by Health Sciences Authority (SG)

Basic Information

GASTROGRAFIN SOLUTION

SOLUTION

Regulatory Information

SIN05846P

May 14, 1991

General Sale List

Therapeutic

ORAL, RECTAL

August 10, 2023

May 30, 2025

XP01CB01

Company Information

BERLIMED S A

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Active Ingredients

SODIUM AMIDOTRIZOATE

Strength: 0.1 g/ml

MEGLUMINE AMIDOTRIZOATE

Strength: 0.66 g/ml

Detailed Information

Contraindications

**Contraindications** Gastrografin must not be administered undiluted in patients with low plasma volume, as for example in newborns, infants, children and in dehydrated patients, since hypovolemic complications can be particularly serious in these patients. Gastrografin must not be administered undiluted in patients with suspected possibility of aspiration or broncho-esophageal fistula, since hyperosmolarity may cause acute pulmonary edema, chemical pneumonia, respiratory collapse and death. Manifest hyperthyroidism.

Indication Information

**Indications** Gastrografin is a contrast medium for the radiological examination of the gastrointestinal tract. It can be administered orally and as an enema and is primarily indicated in cases in which the use of barium sulfate is unsatisfactory, undesirable or contraindicated. Among these are: Threatening perforation (peptic ulcer, diverticulum), after resection of the stomach or the intestine (danger of perforation or leak), suspected partial or complete stenosis, acute haemorrhage, other acute conditions which are likely to require surgery, megacolon, visualization of a foreign body or tumour before endoscopy, visualization of a gastrointestinal fistula. In addition to these conditions Gastrografin can generally be used for the same purposes as barium sulfate. In combination with barium sulfate, Gastrografin has considerably improved routine investigation of the gastrointestinal tract both from a diagnostic and from an organizational point of view – the latter by speeding up the examination. It is unsuitable only for the diagnosis of enteritis. **Further indications:** 1. Early diagnosis of a radiologically undetectable perforation or anastomotic defect in the oesophagus and/or gastrointestinal tract 2. Treatment of meconium ileus 3. Computerized tomography in the abdominal region. The danger of false diagnoses is significantly reduced if the intestine is opacified with Gastrografin, especially for differential diagnoses in the minor pelvis. Gastrografin facilitates delimitation of the intestine from neighbouring organs and permits an assessment of changes in the shape of the pancreas

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