GASTROMIRO Solution for oral or rectal administration Ref.[9482] Active ingredients: Iopamidol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Bracco UK, Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ-UK

Therapeutic indications

This medicinal product is for diagnostic use only.

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:

  • Spill into the respiratory tract, for example in:
    • swallowing disorders
    • oesophageal obstruction with a foreign body, atresia or stricture
    • tracheo-oesophageal fistula.
  • Spill into the mediastinum, pleura, peritoneum or retroperitoneal tissues, for example due to perforation of the GIT.
  • Inspissation of fluid, for example in:
    • Meconium ileus equivalent.
    • Intussusception.
    • Colonic obstruction.
    • Hirschsprung’s disease.

2. Adult radiology of the gastro-intestinal tract, such as:

  • 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.
  • Computer Tomography (CT) of the abdominal and pelvic regions, for example:
    • Suspicion of expanding lesions of pancreas, liver and gall bladder.
    • Space occupying metastatic lesions originating from prostate or recto-sigmoidal region in post-surgical staging of cancer.

Posology and method of administration

The dosage of Gastromiro should be adjusted according to age, total weight, the segment of the digestive tract to be examined and the X-ray procedure.

It must not be used for parenteral administration.

Adults

Radiology of gastro-intestinal tract

Oral: 40-100ml undiluted.

Rectal: 200ml of a 50% dilution, up to 1000ml of a 2% dilution.

Computer Tomography

Oral:

Abdominal CT: 100ml of a 17% dilution, up to 600ml of a 3% dilution.

Rectal – Pelvic CT: 500-700ml of a 3% dilution.

Infants and Children

Radiology of gastro-intestinal tract

Oral: 10-100ml undiluted or, for use in infants 20-200ml of up to a 50% dilution to provide isotonic contrast medium.

Rectal: 200ml of 50-60% dilution.

Elderly

Dosage as for adults.

Dilution of Gastromiro should be carried out using sterile water. Any unused solution should be discarded after 6 hours.

Overdose

The contrast agent is very poorly absorbed by the gastrointestinal tract; therefore, any accumulation of the contrast medium in humans due to overdosage is negligible.

In the event of overdose, treatment is directed toward the support of all vital functions and prompt institution of symptomatic therapy.

Shelf life

Three years.

Special precautions for storage

Protect from light.

Nature and contents of container

The containers are amber glass bottles (Type III) with aluminium screw caps, guarantee seals, and elastomer inserts.

Boxes of 1 bottle 20ml.
Boxes of 1 bottle 50ml.
Boxes of 1 bottle 100ml.

Special precautions for disposal and other handling

Gastromiro is formulated for gastro-intestinal use only and should not be administered parenterally.

The bottle once opened has to be used immediately. Solutions not used in one examination session must be discarded.

Discard in case of discolouration or presence of undissolved particles.

< Previous: Overview
Next: Precautions >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈