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GASTROMIRO is a brand name for Iopamidol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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: i) Spill into the respiratory tract, for example in: a) swallowing disorders b)…
Verbatim from this product's MHRA label. Tap a section to expand.
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.
The undesirable effects reported with Gastromiro were, in general, non- serious, mild to moderate, transient and resolved spontaneously without residual effects. Solutions of iodinated contrast media administered oral route or by enema can cause diarrhoea due to high osmolality of these solutions.
Anaphylactoid reactions/hypersensitivity may manifest with: mild localized or more diffuse angioneurotic oedema, tongue oedema, laryngospasm or laryngeal oedema, pulmonary oedema, circulatory arrest, respiratory arrest, dysphagia, pharyngitis and throat tightness, pharyngolaryngeal pain, cough, conjunctivitis, rhinitis, sneezing, feeling hot, sweating increased, asthenia, dizziness, pallor, dyspnoea, wheezing, bronchospasm, and moderate hypotension.
Skin reactions may occur in the form of various types of rash, diffuse erythema, diffuse blisters, urticaria, and pruritus. These reactions, which occur irrespective of the dose administered and the route of administration, may represent the first signs of incipient state of shock.
Administration of the contrast medium must be discontinued immediately and – if necessary – specific treatment initiated via a venous access. More severe reactions involving the cardiovascular system such as vasodilatation with pronounced hypotension, tachycardia, dyspnoea, agitation, cyanosis and loss of consciousness (syncope) may require emergency treatment.
7%). These reactions have been reported mostly after oral administration of the contrast agent. The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).
Adult population Adverse reactions derived from clinical trials in 269 adult patients who received Iopamidol by either oral or rectal route of administration and from post-marketing spontaneous reporting are tabulated below Adverse Reactions Clinical Trials Post- marketing Surveillance System Organ Class Common >1/100 to <1/10 Uncommon ≥ 1/1,000 to < 1/100 Frequency not known Immune system disorders Anaphylactoi d reaction Vascular disorders Hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Gastrointestinal disorders Vomiting Diarrhoea, Abdominal discomfort Skin and subcutaneous tissue disorders Rash Paediatric population The table below lists the adverse reactions derived from clinical trials conducted in 335 paediatric patients, who received Iopamidol by either oral or rectal route of administration.
4. 1 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: 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: a) Meconium ileus equivalent. b) Intussusception. c) Colonic obstruction.
d) 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. ii. 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. 2 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.
Hypersensitivity to the active ingredient iopamidol or to any of the excipients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Iopamidol in United Kingdom.
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Adverse Reactions Clinical Trials System Organ Class Common >1/100 to <1/10 Uncommon >1/1000 to <1/100 Gastrointestinal disorders Diarrhoea Nausea, Vomiting No cases were received as post-marketing spontaneous reporting. No anaphylactoid reaction has been reported in children after oral or rectal administration of iopamidol however they have been reports of such reactions after parenteral administration of iopamidol.
4 Special warnings and precautions for use). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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. 3 Contraindications Hypersensitivity to the active ingredient iopamidol or to any of the excipients. 4 Special warnings and precautions for use Diagnostic procedures which involve the use of any radiopaque medium should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed.
Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reaction to the contrast medium itself. Disturbances in water or electrolyte balance must first be corrected.
This product is formulated for gastro-intestinal use only and should not be used parenterally. Care should also be exercised in patients with severe functional impairment of the liver, kidney or myocardium, severe systemic disease and in myelomatosis.
In such patients adequate hydration should be maintained and parameters of hepatic and renal function, especially urinary output should be monitored after the procedure. Patients with hepato-renal insufficiency should not be examined unless benefits clearly outweigh risks and re-examination should be delayed for 5-7 days.
The risk of severe hypersensitivity reactions may be increased in patients with history of known clinical hypersensitivity to any of the ingredients, other contrast media or history of asthma or other allergic disorders. In case of suspected perforation of the gastrointestinal tract, use only when the benefit of the information outweighs the risk.
Concomitant administration of β-blockers can exacerbate severe hypersensitivity reactions as emergency medication which may be used to treat any side effects caused by Gastromiro may not be effective. X-ray examination of women should be conducted as far as possible during the pre-ovulation phase of the menstrual cycle.
This product may interfere with tests of thyroid function. Aspiration of orally administered contrast medium into the tracheobronchial tree can result in pulmonary complications therefore avoid use of Iopamidol solution in patients with oesophagotracheal fistula and minimize risks for pulmonary aspiration in all patients.
If the contrast medium is given by nasogastric tube, the position of the tube in the stomach must be verified before administration. 4 mg of ethanol per mL which may be harmful for those suffering from alcoholism, and to be taken into account in pregnant or breast- feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
5mg in 20ml, 11,3 mg in 50ml and 22,5 mg in 100ml corresponding respectively to 0,22%, 0, 55% and 1,12% of the recommended WHO maximum daily intake of 2 g of sodium for an adult. Special populations Women of child bearing potential Appropriate investigations and measures should be taken when exposing women of child- bearing potential to any X-ray examination, whether with or without contrast medium.
Paediatric population Newborns and infants Infants (age<1year), and especially newborns are particularly susceptible to electrolyte imbalances and haemodynamic alterations. It is recommended that they are adequately hydrated prior to administration of Iopamidol solution.
Transient hypothyroidism may occur in neonates when the mother or the neonate has received an iodinated contrast agent. Thyroid function tests (usually TSH and T4) are recommended in neonates 7-10 days and 1 month after exposure to Gastromiro, especially in preterm neonates.