Gastrografin, 660mg/ml and 100mg/ml Oral and Rectal Solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-11-2022
Summary of Product characteristics
(SPC)
21-11-2022
Active ingredient:
Sodium amidotrizoate; Amidotrizoate meglumine; AMIDOTRIZOIC ACID; Meglumine
Available from:
Bayer Limited
ATC code:
V08AC; V08AC08
INN (International Name):
Sodium amidotrizoate; Amidotrizoate meglumine; AMIDOTRIZOIC ACID; Meglumine
Dosage:
660 and 100 milligram(s)/millilitre
Pharmaceutical form:
Oral/rectal solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Watersoluble, hepatotropic X-ray contrast media; sodium iopodate
Authorization status:
Marketed
Authorization date:
1983-04-01
Patient Information leaflet
BP22036_REC30610
1
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
GASTROGRAFIN
®
660MG/ML + 100 MG/ML
ORAL AND RECTAL SOLUTION
MEGLUMINE AMIDOTRIZOATE
SODIUM AMIDOTRIZOATE
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 the doctor giving you
Gastrografin (the radiologist) or
the X-ray department staff.
•
If you get any side effects, talk to
your doctor or the X-ray
department staff/radiologist. This
includes any possible side effects
not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT GASTROGRAFIN IS AND WHAT
IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN GASTROGRAFIN
3.
HOW YOU WILL BE GIVEN
GASTROGRAFIN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE GASTROGRAFIN
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
7.
INFORMATION FOR HEALTHCARE
PROFESSIONALS ONLY.
1.
WHAT GASTROGRAFIN IS AND WHAT
IT IS USED FOR
Gastrografin is a contrast medium (a
dye) which contains iodine. It is used
to clearly show on X-rays the area of
your body that your doctor wants to
investigate. This will be your gullet
(oesophagus), stomach or intestines
(gastrointestinal tract). It may also be
used to treat an intestinal obstruction
in newborn babies (meconium ileus).
X-rays, like radio waves, can pass
through objects and can be focused
to make a picture. When you have an
X-ray, the beam of rays goes through
your body where it is absorbed to
differing degrees by different tissues
such as bones, muscles and organs.
When the rays come out on the other
side they make a pattern of light and
shade on a film. Gastrografin helps to
make this pattern clearer. The film is
then examined by a specialist who will
make a diagnosis.
This medicine is for diagnostic use
only.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN GASTROGRAFIN
DO NOT USE GASTROGRAFIN:
•
If you are, allergic
(hypersensitive) to meglumine
amidotrizoate, sodium
amidotrizoate or any o
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
21 November 2022
CRN00D8K3
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gastrografin, 660mg/ml and 100mg/ml Oral and Rectal Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains Amidotrizoic acid (dihydrate) equivalent
to 597.30 mg Amidotrizoic acid (anhydrous), 159.24 mg
meglumine and 6.29 mg sodium hydroxide equivalent to 100 mg of sodium
amidotrizoate and 660 mg of meglumine
amidotrizoate (and containing the equivalent of 370 mg of iodine in
combined form per ml).
Excipients: Each ml also contains 3.76mg of sodium or 0.16mmol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral and rectal solution.
Clear, almost colourless, yellowish, aqueous solution with a faint
odour of star anise oil.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for use by oral or rectal administration
only.
Gastrografin is a contrast medium for the radiological examination of
the gastrointestinal tract (also in combination with
barium sulphate). It can be administered orally or as an enema and is
primarily indicated in cases in which the use of barium
sulfate is unsatisfactory, undesirable or contraindicated.
These include suspicion of a radiologically undetectable perforation
in the gastrointestinal tract, where acute gastrointestinal
haemorrhage exists or is a significant risk, or there is suspected
bowel obstruction, or where it is necessary to visualise fistulae
of the tract, foreign bodies, or tumours prior to surgery.
For radiological investigation of the gastrointestinal tract in cases
in whom perforation or acute gastrointestinal haemorrhage
exists or is a significant risk, or there is suspected bowel
obstruction, or where it is necessary to visualise fistulae of the
tract,
foreign bodies, or tumours prior to surgery.
In combination with barium sulphate, Gastrografin has considerably
improved routine investigation of the gastrointestinal tract
both from a diagnostic and from an or
Read the complete document
