Gastromiro 612.4mg/ml oral or rectal solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-09-2021
Summary of Product characteristics
(SPC)
23-01-2021
Active ingredient:
Iopamidol
Available from:
Bracco Imaging spa
ATC code:
V08AB; V08AB04
INN (International Name):
Iopamidol
Dosage:
612.4 milligram(s)/millilitre
Pharmaceutical form:
Oral/rectal solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Watersoluble, nephrotropic, low osmolar X-ray contrast media; iopamidol
Authorization status:
Marketed
Authorization date:
1990-04-10
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
GASTROMIRO
612.4MG/ML ORAL OR RECTAL SOLUTION
IOPAMIDOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
- This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
IN THIS LEAFLET:
1. What Gastromiro is and what it is used for
2. What you need to know before you use Gastromiro
3. How to use Gastromiro
4. Possible side effects
5. How to store Gastromiro
6. Contents of the pack and information
1. WHAT GASTROMIRO IS AND WHAT IT IS USED FOR
Gastromiro is an X-ray contrast medium. This is a special dye which is
opaque to X-rays because it contains
iodine.
X-ray radiation is used to obtain an image of the tissues of the body.
The rays are directed on to the area of
the body being investigated and pass through it to record an image on
photographic film. If the doctor needs
to highlight a particular area of the body to get better information,
he/she will carry out a contrast X-ray. This
means that a dye which absorbs X-rays will be used.
Gastromiro is such a dye.
It has been specially made into a drink or given as enema for
investigation of the digestive system.
Because of its special formulation Gastromiro is used particularly in
situations where it is possible that some
dye could leak outside the digestive system. It is also particularly
suited to babies and children.
Gastromiro may also be used if you are having a CAT scan (Computer
Axial Tomography).
This medicine is for diagnostic use only.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GASTROMIRO
Gastromiro should only be given to you in a hospital or clinic where
there are equipment and medically
trained staff able to deal with allergic reactio
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Summary of Product characteristics
Health Products Regulatory Authority
22 January 2021
CRN009RRT
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gastromiro 612.4mg/ml oral or rectal solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 612.4mg iopamidol equivalent to 300mg
iodine.
Excipients with known effect:
sodium 0.225 mg/ml (sodium cyclamate, disodium edetate dihydrate,
sodium saccharinate), ethanol 2.42 mg/ml (orange and
Red CuraVao flavours)
For full lists of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral or rectal solution.
A clear, particle-free solution with an orange odour and flavour.
4 CLINICAL PARTICULARS
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.
Health Products Regulatory Authority
22 January 2021
CRN009RRT
Page 2 of 7
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.
4.2 POSOLOGY AND ME
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