GASTROGRAFIN SOLUTION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MEGLUMINE AMIDOTRIZOATE; SODIUM AMIDOTRIZOATE

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

P01CB01

Dosage:

0.66 g/ml

Pharmaceutical form:

SOLUTION

Composition:

MEGLUMINE AMIDOTRIZOATE 0.66 g/ml; SODIUM AMIDOTRIZOATE 0.1 g/ml

Administration route:

ORAL, RECTAL

Prescription type:

General Sale List

Manufactured by:

BERLIMED S A

Authorization status:

ACTIVE

Authorization date:

1991-05-14

Patient Information leaflet

Gastrografin Solution
GASTROGRAFIN®

Important information, please read carefully !
 COMPOSITION
100 ml Gastrografin contain 10 g sodium amidotrizoate and 66 g
meglumine amidotrizoate 
(sodium diatrizoate and meglumine diatrizoate) in aqueous solution. 
 PHARMACODYNAMIC/PHARMACOKINETIC PROPERTIES
PHARMACODYNAMIC PROPERTIES
The contrast-giving substance of Gastrografin is a salt of the
amido(dia-)trizoic acid in 
which the X-ray absorbing iodine is present in stable chemical
bond. The physico-chemical 
characteristics of Gastrografin listed below are: 
PHARMACOKINETIC PROPERTIES 
Absorption of amidotrizoic acid, the radiopaque agent
of Gastrografin, following oral 
administration is only 3 %. Even in the absence of perforation a
higher absorption was 
observed in some patients demonstrated by opacification of the renal
calyces and ureters. 
If a perforation of the gastrointestinal tract is
present, Gastrografin finds its way into the 
abdominal cavity or the surrounding tissue, where it is absorbed and
finally excreted via the 
kidneys. 
 INDICATIONS 
Gastrografin is a contrast medium for the radiological examination
of the gastrointestinal 
tract. It can be administered orally and as an enema and is primarily
indicated in cases in 
which the use of barium sulfate is unsatisfactory, undesirable or
contraindicated. 
Among these are: 
Threatening perforation (peptic ulcer, diverticulum), after
resection of the stomach or the 
intestine (danger of perforation or leak), suspected partial or
complete stenosis, acute 
haemorrhage, other acute conditions which are likely to require
surgery, megacolon, 
visualization of a foreign body or tumour before endoscopy
, visualization of a 
gastrointestinal fistula. 
In addition to these conditions Gastrografin can generally be used for
the same purposes as 
barium sulfate.
In combination with barium sulfate, Gastrografin has considerably
improved routine 
investigation of the gastrointestinal tract both from

Summary of Product characteristics

Gastrografin CCDS 7 _07.01.2019
GASTROGRAFIN
Gastrografin Solution
COMPOSITION
100 ml Gastrografin contain 10 g sodium amidotrizoate and 66 g
meglumine amidotrizoate
(sodium diatrizoate and meglumine diatrizoate) in aqueous solution.
PHARMACODYNAMIC/PHARMACOKINETIC PROPERTIES
PHARMACODYNAMIC PROPERTIES
The contrast-giving substance of Gastrografin is a salt of the
amido(dia-)trizoic acid in which
the X-ray absorbing iodine is present in stable chemical bond. The
physico-chemical
characteristics of Gastrografin listed below are:
Iodine concentration (mg/ml)
370
Osmolality (osm/kg H
2
O) at 37 °C
2.15
Viscosity (mPa·s)
at 20 °C
at 37 °C
18.5
8.9
Density (g/ml)
at 20 °C
at 37 °C
1.427
1.417
pH-value
6.0-7.0
PHARMACOKINETIC PROPERTIES
Absorption
of
amidotrizoic
acid,
the
radiopaque
agent
of
Gastrografin,
following
oral
administration is only 3 %. Even in the absence of perforation a
higher absorption was
observed in some patients demonstrated by opacification of the renal
calyces and ureters.
If a perforation of the gastrointestinal tract is present,
Gastrografin finds its way into the
abdominal cavity or the surrounding tissue, where it is absorbed and
finally excreted via the
kidneys.
INDICATIONS
Gastrografin is a contrast medium for the radiological examination of
the gastrointestinal
tract. It can be administered orally and as an enema and is primarily
indicated in cases in
which the use of barium sulfate is unsatisfactory, undesirable or
contraindicated.
Among these are:
Threatening perforation (peptic ulcer, diverticulum), after resection
of the stomach or the
intestine (danger of perforation or leak), suspected partial or
complete stenosis, acute
haemorrhage,
other
acute
conditions
which
are
likely
to require surgery,
megacolon,
visualization
of
a
foreign
body
or
tumour
before
endoscopy
,
visualization
of
a
gastrointestinal fistula.
Gastrografin CCDS 7 _07.01.2019
In addition to these conditions Gastrografin can generally be used for
the same purposes as
barium sulfate.
In
combination
with
barium
sulfate