Gastrografin Oral Liquid Bottle

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

amidotrizoate meglumine, Quantity: 660 mg/mL; sodium amidotrizoate, Quantity: 100 mg/mL

Saadav alates:

Bayer Australia Ltd

Ravimvorm:

Oral Liquid, solution

Koostis:

Excipient Ingredients: disodium edetate; Anise Oil; polysorbate 80; saccharin; purified water

Manustamisviis:

Oral

Ühikuid pakis:

250mL, 100mL

Klass:

Medicine Registered

Retsepti tüüp:

Not scheduled. Not considered by committee

Näidustused:

Gastrografin is a contrast medium for examination of the gastrointestinal tract. It can be administered orally and as enema and is primarily indicated in cases in which the use barium sulfate is unsatisfactory, undesirable or contraindicated. Among these are: - suspected partial or complete stenosis - acute haemorrhage - threatening perforation (peptic ulcer, diverticulum) - other acute conditions which are likely to require surgery - after resection of the stomach or the intestine (danger of perforation or leak) - megacolon - visualisation of a foreign body or tumour before endoscopy - visualisation of gastrointestinal fistula. In addition to these conditions Gastrografin can generally be used for the same purposes as barium sulfate with the exception of the visualisation 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 inve

Toote kokkuvõte:

Visual Identification: A clear colourless liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

1991-08-19

Infovoldik

GASTROGRAFIN®
1
GASTROGRAFIN®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I GIVEN GASTROGRAFIN?
GASTROGRAFIN contains the active ingredients sodium amidotrizoate and
amidotrizoate meglumine. GASTROGRAFIN is a
contrast agent used during an X-ray examination.
For more information, see Section 1. Why am I given GASTROGRAFIN? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN GASTROGRAFIN?
Do not use if you have ever had an allergic reaction to GASTROGRAFIN
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR, RADIOGRAPHER OR NURSE IF YOU HAVE ANY OTHER
MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE
PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
The X-ray picture is improved if your bowels are emptied. A cleansing
of the bowels before you are given GASTROGRAFIN is
recommended. Your doctor, radiographer or nurse will advise you on
this. It is important that you still drink fluids as normal.
For more information, see Section 2. What should I know before I am
given GASTROGRAFIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GASTROGRAFIN and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN GASTROGRAFIN?
GASTROGRAFIN is given different ways depending on your examination. It
will be given by either drinking the solution or as an
enema by your doctor, radiographer or nurse.
More instructions can be found in Section 4. How am I given
GASTROGRAFIN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING GASTROGRAFIN?
THINGS YOU
SHOULD DO
Tell your doctor, radiographer or nurse if you:
•
experience any of the severe symptoms of loss of consciousness or
heart attack, increase in heart
rate, difficulty breathing, low blood pressure and swelling of the
face, lips or tongue leading to
severe breathing difficulties a

Toote omadused

1
190213 Gastrografin PI
AUSTRALIAN PRODUCT INFORMATION
GASTROGRAFIN
®
Sodium amidotrizoate / Amidotrizoate meglumine
Oral Liquid
1.
NAME OF THE MEDICINE
Sodium amidotrizoate / Amidotrizoate meglumine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mL gastroenteral solution contains 10 g sodium amidotrizoate and
66 g amidotrizoate meglumine
(sodium diatrizoate and meglumine diatrizoate).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Presentation
Gastrografin is a clear, faintly yellowish, aqueous, ionic, hypertonic
solution.
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 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:
-
suspected partial or complete stenosis
-
acute haemorrhage
-
threatening perforation (peptic ulcer, diverticulum)
-
other acute conditions which are likely to require surgery
-
after resection of the stomach or the intestine (danger of perforation
or leak)
-
megacolon
-
visualisation of a foreign body or tumour before endoscopy
-
visualisation of gastrointestinal fistula
In addition to these conditions Gastrografin can generally be used for
the same purposes as barium
sulfate with the exception of the visualisation 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 investigation of the
gastrointestinal tract both from a diagnostic and from an
organisational point of view –in the latter case
by speeding up the examination. It is unsuitable only for the
diagnosis of enteritis.
2
190213 Gastrografin PI
Further indications:
a)
Early diagnosis of a radiologically undetectable pe