Gastrografin oral solution

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Sodium amidotrizoate; Meglumine amidotrizoate

Dostupné z:

Bayer Plc

INN (Medzinárodný Name):

Sodium amidotrizoate; Meglumine amidotrizoate

Dávkovanie:

100mg/1ml ; 660mg/1ml

Forma lieku:

Oral solution

Spôsob podávania:

Rectal; Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 18030000; GTIN: 5016703008323

Príbalový leták

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Page 1 of 5
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
GASTROGRAFIN® GASTROENTERAL SOLUTION
SODIUM AMIDOTRIZOATE AND MEGLUMINE AMIDOTRIZOATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 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
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

Súhrn charakteristických

OBJECT 1
GASTROGRAFIN
Summary of Product Characteristics Updated 10-Oct-2017 | Bayer plc
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:
• 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