Urografin 30 %w/v Solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Meglumine; Sodium hydroxide ; Sodium amidotrizoate

Available from:

Bayer Limited

ATC code:

V08AA01

INN (International Name):

Meglumine; Sodium hydroxide ; Sodium amidotrizoate

Dosage:

30 percent weight/volume

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to Restricted Prescription (C)

Therapeutic area:

diatrizoic acid

Authorization status:

Marketed

Authorization date:

1988-04-01

Patient Information leaflet

BP22036_REC30610
PACKAGE LEAFLET: INFORMATION FOR
THE USER
UROGRAFIN
® 30% W/V
SOLUTION FOR INFUSION
Sodium amidotrizoate
Meglumine amidotrizoate
Read all of this leaflet carefully before
you are given this medicine
•
Keep this leaflet. You may need
to read it again.
•
If you have any further questions,
ask the doctor giving you
Urografin (the radiologist) or the
X-ray department staff.
•
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or the X-
ray department staff/radiologist.
IN THIS LEAFLET:
1.
WHAT UROGRAFIN IS AND WHAT IT
IS USED FOR
2.
BEFORE YOU ARE GIVEN UROGRAFIN
3.
HOW YOU WILL BE GIVEN
UROGRAFIN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE UROGRAFIN
6.
FURTHER INFORMATION
1.
WHAT UROGRAFIN IS AND WHAT IT
IS USED FOR
Urografin is an injectable contrast
medium (a dye) which contains
iodine. It is used to show the urinary
tract clearly on X-rays.
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. Urografin helps to
make this pattern clearer. The film is
then examined by a specialist who will
make a diagnosis.
This medicine is for diagnostic use
only.
2.
BEFORE YOU ARE GIVEN UROGRAFIN
DO NOT USE UROGRAFIN IF:
•
you are, or suspect you are,
allergic (hypersensitive) to iodine
or iodine- containing contrast
media or any of the other
ingredients of Urografin ( see
section 6: Further Information)
•
you have an overactive thyroid
gland which is not being fully
treated (manifest
hyperthyroidism).
•
you have heart failure.
Urografin must not be given into the
space around the spinal cord
because severe adverse reactions
are possible.
TAKE SPECIAL CARE WITH UROGRAFIN
You must tell the X-ray department
staff if you have any of the following:

Summary of Product characteristics

Health Products Regulatory Authority
21 November 2022
CRN00D8K3
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Urografin 30 %w/v Solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Urografin 30% for infusion contains 0.04 g sodium
amidotrizoate and 0.26 g meglumine amidotrizoate (sodium
diatrizoate and meglumine diatrizoate) in aqueous solution, containing
the equivalent of 146 mg of Iodine in combined form
per ml.
Excipients: Contains 1.45mg (0.063mmol) sodium per ml (Each 250ml
bottle contains 362.5mg sodium).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless to faintly yellow, odourless, sterile aqueous
solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Infusion urography.
UROGRAFIN IS NOT TO BE USED FOR MYELOGRAPHY, VENTRICULOGRAPHY OR
CISTERNOGRAPHY, SINCE IT IS LIKELY TO PROVOKE
NEUROTOXIC SYMPTOMS IN THESE EXAMINATIONS.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL INFORMATION
o 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 newborns, infants and young children, however, prolonged fasting
and the administration of a laxative before the
examination are contraindicated.
o 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, infants, small
children and elderly patients. Disorders of water and electrolyte
balance must be corr