Urografin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

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

Available from:

Bayer New Zealand Limited

INN (International Name):

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

Dosage:

76 %

Pharmaceutical form:

Solution for infusion

Composition:

Active: Meglumine amidotrizoate 660 mg/mL (formed from meglumine and amidotrizoic acid) Sodium amidotrizoate 100 mg/mL (formed from sodium hydroxide and amidotrizoic acid) Excipient: Sodium calcium edetate Water for injection

Units in package:

Bottle, glass, Hanger label, 50 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

Justesa Imagen S.A.

Therapeutic indications:

Intravenous and retrograde urography. Also for all angiographic examinations as well as for amniography, arthrography, intraoperative cholangiography, endoscopic retrograde cholangiopancreatography (ERCP), sialography, 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 these examinations.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, Hanger label - 50 mL - 60 months from date of manufacture stored at or below 30°C. Protect from light, heat and secondary x-rays - Bottle, glass, - 100 mL - 60 months from date of manufacture stored at or below 30°C. Protect from light, heat and secondary x-rays

Authorization date:

1969-12-31

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
1811 Urografin datasheet
DATA SHEET
UROGRAFIN®
(Sodium amidotrizoate/ Amidotrizoate meglumine)
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
Solution for injection or infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intravenous and retrograde urography.
Also for all angiographic examinations as well as for amniography,
arthrography,
intraoperative cholangiography, endoscopic retrograde
cholangiopancreatography
(ERCP), sialography, 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 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,
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 pm. 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 with
nephropathy, polyuria, oliguria, hyperuricaemia, as well as to
newborns, infant