GASTROMIRO Solution for oral or rectal administration (2020)
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Περιεχόμενα
Name of the medicinal product
Gastromiro.
Qualitative and quantitative composition
Active component Quantity 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 ...
Pharmaceutical form
Gastromiro is an aqueous colourless to pale yellow solution for oral or rectal administration (enema).
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 ...
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. ...
Contraindications
Hypersensitivity to the active ingredient iopamidol or to any of the excipients.
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 ...
Interaction with other medicinal products and other forms of interaction
Concomitant administration of β-blockers can exacerbate severe hypersensitivity reactions. No interaction studies have been performed. There are no known interactions.
Pregnancy and lactation
Pregnancy There are no or a limited amount of data from the use of Iopamidol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. ...
Effects on ability to drive and use machines
Gastromiro has no or negligible influence on the ability to drive and use machines.
Undesirable effects
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 ...
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 ...
Pharmacodynamic properties
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 ...
Pharmacokinetic properties
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. ...
Preclinical safety data
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 ...
List of excipients
Excipients Quantity per ml: Orange flavour 2.2 mg Sodium cyclamate 1.5 mg Red Curaςao flavour 1.1 mg Disodium edetate dihydrate 0.3 mg Sodium saccharinate 0.176 mg Citric acid monohydrate 0.055 mg Water ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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 ...
Marketing authorization holder
Bracco UK, Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ-UK
Marketing authorization number(s)
PL 18920/0036
Date of first authorization / renewal of the authorization
9 January 1991 / 9 January 1996
Date of revision of the text
28 January 2020
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