Gastrografin

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Meglumine amidotrizoate 660 mg/mL (formed from melgumine and amidotrizoic acid); Sodium amidotrizoate 100 mg/mL (formed from sodium hydroxide and amidotrizoic acid)

متاح من:

Bayer New Zealand Limited

INN (الاسم الدولي):

Meglumine amidotrizoate 660 mg/mL (formed from melgumine and amidotrizoic acid)

الشكل الصيدلاني:

Oral solution

تركيب:

Active: Meglumine amidotrizoate 660 mg/mL (formed from melgumine and amidotrizoic acid) Sodium amidotrizoate 100 mg/mL (formed from sodium hydroxide and amidotrizoic acid) Excipient: Anise oil Disodium edetate Polysorbate 80 Purified water Saccharin sodium

الوحدات في الحزمة:

Bottle, glass, 10 x 100mL bottles, 1 L

الفئة:

General sale

نوع الوصفة الطبية :

General sale

المصنعة من قبل:

Justesa Imagen S.A.

ملخص المنتج:

Package - Contents - Shelf Life: Bottle, glass, 100mL bottles - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 72 hours opened stored at or below 25°C protect from light - Bottle, glass, - 100 mL - 24 months from date of manufacture stored at or below 25°C protect from light 72 hours opened stored at or below 25°C protect from light

تاريخ الترخيص:

1969-12-31

نشرة المعلومات

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

خصائص المنتج

1
1811 Gastrografin Datasheet
DATA SHEET
GASTROGRAFIN
®
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
Oral 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 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. 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 a gastrointestinal fistula
• small bowel obstruction
• postoperative ileus
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 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
1811 Gastrografin Datasheet
Further indications:
a)
early diagnosis of a radiologically undetectable perforation or
anastomotic