Gastromiro

Iopamidol 61.24 % w/v

Gastromiro is an aqueous solution for oral or rectal administration (enema)

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:

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

Adults:

Radiology of gastro-intestinal tract

Computer Tomography

Oral:

Infants and Children:

Radiology of gastro-intestinal tract

Elderly:

Dosage as for adults.

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

Proven or suspected hypersensitivity to iodine containing preparations of this type. It must not be used for parenteral administration.

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 5-7days.

In patients with a history of adverse reactions during similar investigations additional caution should be exercised and the procedure should only be carried out if benefits clearly outweigh any risks.

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, to minimise the risks for pulmonary aspiration in patients if the contrast medium is given by nasogastric tube, the position of the tube in the stomach must be verified before administration.

None known

The safety of iopamidol during pregnancy and lactation has not been demonstrated clinically. Due, however, to the extremely low absorption of iopamidol from the gastro-intestinal tract it is unlikely that a foetus could be exposed to significant levels. In animal experiments iopamidol is neither teratogenic nor foetotoxic. Similarly, during lactation breast fed infants are unlikely to be exposed to significant levels of iopamidol. However, the product should not be used during pregnancy or when breast feeding unless considered essential.

None known.

The undesirable effects reported with Gastromiro were, in general, non-serious, mild to moderate, transient and resolved spontaneously without residual effects.

Anaphylactoid reactions/hypersensitivity may manifest with: mild localized or more diffuse angioneurotic oedema, tongue oedema, laryngospasm or laryngeal oedema, 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.

In clinical trials, the most commonly reported adverse reactions are vomiting in adult patients (1.8%) and diarrhoea in paediatric patients (5.7%). 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

Paediatric population

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.

Following oral administration of Gastromiro, aspiration, manifested with coughing and possible pulmonary complications, has been reported (see section 4.4 Special warnings and precautions for use).

The contrast agent is not absorbed from the gastrointestinal tract, therefore any systemic accumulation of the contrast medium following overdosage will not occur. Any treatment should be symptomatic.

Iopamidol is a contrast medium belonging to the new generation of non-ionic compounds whose solubility is due to the presence of hydrophilic substituents in the molecule. This results in a solution of low osmolality when compared with ionic media.

Iopamidol has been shown to be effective as an X-ray contrast medium in neuroradiology, angiography, venography, arthrography, urography, cerebral angiography, and left ventriculography, coronary arteriography, and investigations of the gastrointestinal tract. Its toxicity, particularly cardiac and CNS toxicity, is less than those of ionic contrast media.

Serum iopamidol concentration curves conform to an open two compartment pharmacokinetic model with first order elimination. Iopamidol is very poorly absorbed (about 1-2%) after oral or rectal administration.

Distribution volume is equivalent to extracellular fluid.

Following parenteral administration elimination is almost completely through the kidneys. Less than 1% of the administered dose has been recovered in the faeces up to seventy two hours after dosing. Renal elimination is rapid and up to half the administered dose may be recovered in the urine within the first two hours of dosing.

There is no evidence of biotransformation.

Serum protein binding is negligible.

In animals, Gastromiro was well tolerated after repeated oral administration. After 4 weeks adminstration of Gastromiro equivalent to 9 gI/kg day, i.e. about 20 times higher than the recommended clinical dose, no severe symptoms of sub-acute intoxication were observed in rats. Following intraperitoneal injection of Gastromiro in rats, iopamidol was rapidly cleared and almost totally eliminated by the renal route within the first 24 hours.

The intraperitoneal acute toxicity was relatively low. Necroscopic examination revealed no irritant effects on the peritoneal membrane. Gastromiro also showed good local tolerability after both local intratracheal installation and systemic administration . It therefore offers a good margin of safety for examination in which there is the risk of an accidental inspiration of the diagnostic medium.

No incompatibility studies have been performed: other drugs should not be mixed with Gastromiro.

Three years.

Protect from light.

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

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

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.

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

Gastromiro formulation is a colourless to pale yellow solution containing undissolved solids. Discard in case of discolouration.

Bracco U.K. Ltd,

Bracco House, Mercury Park,

Wycombe Lane, Wooburn Green,

Buckinghamshire HP10 OHH

PL 18920/0012

9 January 1991/ 9 January 1996

16 January 2012