Urografin 76% 100mL injection bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; disodium edetate

Administration route:

Intravenous

Units in package:

100mLx10

Class:

Medicine Registered

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Intravenous and retrograde urography. Computerised tomography. Also for all angiographic examinations as well as for amniography, arthrography, intraoperative cholangiography, fistulography, hysterosalpingography, splenoportography, vesiculography and others. Urografin is not to be used for myelography, ventriculography or cisternography since it is likely to provoke neurotoxic symptoms in the examinations.

Product summary:

Visual Identification: Clear colourless to faintly yellowish solution; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-06-08

Patient Information leaflet

UROGRAFIN®
1
UROGRAFIN®
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 UROGRAFIN?
UROGRAFIN contains the active ingredients sodium amidotrizoate and
amidotrizoate meglumine. UROGRAFIN is a contrast
agent used during an X-ray examination.
For more information, see Section 1. Why am I given UROGRAFIN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN UROGRAFIN?
Do not use if you have ever had an allergic reaction to UROGRAFIN 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.
If you are to have an X-ray of your abdominal area or kidneys, you may
be asked to change your diet for 2 days prior and to not
eat (fast) after 6pm the evening before your procedure. It is
important that you still drink fluids as normal.
For more information, see Section 2. What should I know before I am
given UROGRAFIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with UROGRAFIN 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 UROGRAFIN?
UROGRAFIN is injected by the doctor or radiographer into different
parts of your body depending on the area of your body to
be examined.
More instructions can be found in Section 4. How am I given UROGRAFIN?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING UROGRAFIN?
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 and shock
•
experience any asthma symptoms e.g. chest tightening.
DRIVING OR USING

Summary of Product characteristics

1
190213 Urografin PI
AUSTRALIAN PRODUCT INFORMATION
UROGRAFIN
®
Sodium amidotrizoate / Amidotrizoate meglumine
Injection
1
NAME OF THE MEDICINE
Sodium amidotrizoate / Amidotrizoate meglumine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Urografin 30% contains 40 mg/mL sodium amidotrizoate and 260 mg/mL
amidotrizoate meglumine in
aqueous solution.
Urografin 76% contains 100 mg/mL sodium amidotrizoate and 660 mg/mL
amidotrizoate meglumine
in aqueous solution.
For the full list of
excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Presentation
Urografin is a clear, colourless to faintly yellowish aqueous solution
for injection or infusion
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intravenous and retrograde urography. Computerized tomography.
Also for all angiographic examinations as well as for amniography,
arthrography, intraoperative
cholangiography, fistulography, hysterosalpingography,
splenoportography, vesiculography and
others.
Urografin is not to be used for myelography, ventriculography of
cisternography, since it is likely to
provoke neurotoxic symptoms in these examinations.
4.2
DOSE AND METHOD OF ADMINISTRATION
General information
•
Dietary suggestions
In the case of abdominal angiography and urography, the diagnostic
yield is increased if the bowels
are emptied of faecal matter and gas. On the two days prior to the
examination patients should
therefore avoid flatulent food, in particular peas, beans and lentils,
salads, fruit, dark and fresh bread
and all kinds of uncooked vegetables. On the day before the
examination, patients should refrain
from eating after 6 p.m. Moreover, it can be appropriate to administer
a laxative in the evening. In
babies and young children, however, prolonged fasting and the
administration of a laxative before
the examination are contraindicated.
•
Hydration
Adequate hydration must be assured before and after contrast medium
administration. This applies
especially to patients with multiple myeloma, diabetes mellitus and
nephropathy, polyuria, ol