资料单张
UROGRAFIN 30%
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
UROGRAFIN 30%
Solution for infusion
COMPOSITION
Urografin 30% contains a mixture of
sodium amidotrizoate
and
meglumine amidotrizoate
in a proportion of 10:66 in
aqueous solution (formed from amidotrizoic acid or diatrizoic acid:3,5-bis-acetamido-2,4,6-triiodobenzoic acid).
1 mL Urografin 30% contains sodium amidotrizoate 0,04 g and meglumine amidotrizoate 0,26 g. Each 250 mL bottle
contains sodium amidotrizoate 9,85 g and meglumine amidotrizoate 65,15 g (146 mg I/mL).
PHARMACOLOGICAL CLASSIFICATION
A. 28 Contrast media.
PHARMACOLOGICAL ACTION
Pharmacodynamic properties
The contrast-giving substances of Urografin are salts of the amido(dia-)trizoic acid in which the X-ray absorbing iodine is
present in stable chemical bond. The physico-chemical characteristics of Urografin 30% are:
Iodine concentration (mg/mL) 146
Osmolality (osm/kg H
2
O)
At 37°C
0,71
Viscosity (mPa.s)
At 20°C
At 37°C
2,2
1,4
Density (g/mL)
At 20°C
At 37°C
1,164
1,158
pH-value
6,0-7,0
Pharmacokinetic properties
Distribution
Plasma protein binding following intravenous injection amounts to less than 10%.
A concentration corresponding to 2 to 3 g iodine/litre plasma can be expected 5 minutes after an intravenous bolus
injection of 1 mL Urografin 60%/kg body weight. Over a period of 3 hours, the blood level falls relatively quickly in the
first 30 minutes, then with a half-life of 1 to 2 hours.
Amidotrizoic acid does not penetrate the erythrocytes, it is very quickly distributed in the extracellular space following
intravascular administration, b
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