Gastrografin

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEGLUMINE AMIDOTRIZOATE; SODIUM AMIDOTRIZOATE

Available from:

Bayer PLC

ATC code:

V08AA01

INN (International Name):

MEGLUMINE AMIDOTRIZOATE; SODIUM AMIDOTRIZOATE

Pharmaceutical form:

GASTROENTERAL SOLUTION

Composition:

MEGLUMINE AMIDOTRIZOATE 660 mg/ml; SODIUM AMIDOTRIZOATE 100 mg/ml

Prescription type:

POM

Therapeutic area:

CONTRAST MEDIA

Authorization status:

Authorised

Authorization date:

2007-07-25

Patient Information leaflet

PACKAGING TECHNOLOGY BERLIN SGSMZ
page 1
Bayer AG
client: 138
material-no.: 85989170
PZ: 2793A-3
code-no.: 47
name: LF GASTROGRAFIN GB
country: GB
colors: BLACK
version: 18.07.2017/01
Restricted Document
dimension: 311 X 457 MM

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, ask your doctor giving you
Gastrografin (the radiologist) or the X-ray department staff
R 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. Content of the pack and other information
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:
R if you are allergic to sodium amidotrizoate, meglumine
amidotrizoate, iodine or iodine-containin

Summary of Product characteristics

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Page 1 of 8
1.3.1
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gastrografin gastroenteral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains: 100 mg sodium amidotrizoate (sodium
diatrizoate) and
660 mg meglumine amidotrizoate (meglumine diatrizoate).
Excipients with known effect: disodium edetate, sodium hydroxide,
saccharin
sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastroenteral solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic 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).
Gastrografin may be of particular value in the following instances:
1.
Suspected partial or complete stenosis.
2.
Acute haemorrhage.
3.
Threatening perforation (peptic ulcer, diverticulum).
4.
Other acute conditions which are likely to require surgery.
5.
After resection of the stomach or intestine (danger of perforation or
leak).
6.
Megacolon.
7.
Visualisation of a foreign body or tumour before endoscopy.
8.
Visualisation of a gastrointestinal fistula.
9.
Before Endoscopy
Further indications:
013_0
Page 2 of 8
1.3.1
2

Early diagnosis of a radiologically undetectable perforation or
anastomotic
defect in the oesophagus.

The treatment of uncomplicated meconium ileus.

Computerised tomography in the abdominal region.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage for oral use
The dosage is dependent on the type of examination and the age of the
patient.
_Adults and children of 10 years of age or over_:
Visualisation of the stomach: 60 ml
Follow-through examination of the gastrointestinal tract: a maximum of
100
ml
Computerised tomography (CT)
0.5 -
1.5
litres
of approximately 3% Gastrografin solution (30 ml
Gastrografin/1 litre of water).
_Older and cachectic patients_:
Dilution with an equal volume of water is
recommended.
_Children_
Children (up to 10 y