Gastrografin

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEGLUMINE AMIDOTRIZOATE, SODIUM AMIDOTRIZOATE

Available from:

Bayer Hellas S.A 6-8 Agisilaou Street 151 23 Marousi Attiki, , Greece

ATC code:

V08AA01

INN (International Name):

SODIUM AMIDOTRIZOATE 10 g/100ml MEGLUMINE AMIDOTRIZOATE 66 g/100ml

Pharmaceutical form:

GASTROENTERAL SOLUTION

Composition:

SODIUM AMIDOTRIZOATE 10 g/100ml MEGLUMINE AMIDOTRIZOATE 66 g/100ml

Prescription type:

POM

Therapeutic area:

CONTRAST MEDIA

Authorization status:

Authorised

Authorization date:

2007-07-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GASTROGRAFIN
®
GASTROENTERAL SOLUTION (66% +10%)
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 your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. 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 use Gastrografin
®
3. How to use Gastrografin
®
4. Possible side effects
5. How to store Gastrografin
®
6. Contents of the pack and other information
1. WHAT GASTROGRAFIN
® IS AND WHAT IT IS USED FOR
This medicinal product is provided as a solution for drinking or for
use as an enema.
Gastrografin
®
is a contrast medium, which contains iodine and it is used to conduct
X-ray
examination of the digestive system, including computerized
tomography.
It helps to visualize constrictions, leaks, dilatation, foreign
bodies, tumors, etc. Gastrografin
®
is
usually used when oral or rectal administration of barium is excluded.
However, it can be
combined with barium for the ameliorating the X-ray imaging.
Gastrografin may also be used to
treat an intestinal obstruction in newborn babies (
_meconium ileus_
).
X-rays, like radio waves, can pass through objects and produce an “
picture
”. When you have an
X-ray, the beam of X 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
and enables the radiologist to see the intestine

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
GASTROGRAFIN
®
(Sodium Amidotrizoate, Meglumine Amidotrizoate)
1. NAME OF THE MEDICINAL PRODUCT
Gastrografin
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
100
ml
gastroenteral
solution
contains
10
g
sodium
amidotrizoate
and
66
g
meglumine
amidotrizoate (sodium diatrizoate and meglumine diatrizoate).
Excipient with known effect:
Gastrografin contains sodium, see section 4.4
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Gastroenteral solution, osmolarity (Osm/Kg H
2
O) in 37
o
C: 2.15, pH 6.0 – 7.0
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product intended for diagnostic purposes only and 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 sulfate).
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:
-early diagnosis of a radiologically undetectable perforation or
anastomotic defect in the
oesophagus and/or gastrointestinal tract, threatening for the
patient’s life, suspected perforation
(peptic ulcer, diverticulum) or after resection of the stomach or the
intestine (danger of perforation
or leak)
- suspected partial or complete stenosis, small bowel obstruction,
post-operative ileus, acute
haemorrhage
- other acute conditions which are likely to require surgery
- megacolon
- visualisation of a foreign body or tumour before endoscopy
- visualisation of a gastrointestinal fistula
In addition to these situations, Gastrografin
®
can generally be used for the same purposes as
barium sulfate with the exception of the visualization of mucosal
diseases. Due to the insufficient
coating properties of Gastrografin
®
, barium sulfate should be used for single or double contrast
techniques.
In
combination
with
barium
sulfate,
Gastrografin
®
has
considerably
improved
routine
i