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

Product name and form

Gastromiro.

Pharmaceutical Form

Gastromiro is an aqueous colourless to pale yellow solution for oral or rectal administration (enema).

Qualitative and quantitative composition

Active componentQuantity per ml
iopamidol (I.N.N.) 612.4 mg

Iopamidol 61.24% w/v.

Excipient(s) with known effect: ethanol (2.4 mg per mL) – see section 4.4.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Iopamidol

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

List of Excipients

Excipients – Quantity per ml:

Orange flavour 2.2 mg
Sodium cyclamate 1.5 mg
Red Curaฯ‚ao flavour 1.1 mg
Disodium edetate dihydrate 0.3 mg
Sodium saccharinate 0.176 mg
Citric acid monohydrate 0.055 mg
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Bracco UK, Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ-UK

Marketing authorization dates and numbers

PL 18920/0036

9 January 1991 / 9 January 1996

Drugs

Drug Countries
GASTROMIRO Austria, Estonia, Ireland, United Kingdom

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