资料单张
UROGRAFIN 60% 20 mL
UROGRAFIN 76%
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
UROGRAFIN 60% 20 mL
UROGRAFIN 76%
Solution for injection
COMPOSITION
Urografin 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).
Urografin 60%
1 mL Urografin 60% contains sodium amidotrizoate 0,08 g and meglumine amidotrizoate 0,52 g.
Each 20 mL ampoule contains sodium amidotrizoate 1,60 g and meglumine amidotrizoate 10,40 g (292 mg I/mL).
Urografin 76%
1 mL Urografin 76% contains sodium amidotrizoate 0,10 g and meglumine amidotrizoate 0,66 g.
Each 20 mL ampoule contains sodium amidotrizoate 2,00 g and meglumine amidotrizoate 13,20 g (370 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 are:
Urografin 60% Urografin 76%
Iodine concentration (mg/mL) 292
370
Osmolality (osm/kg H
2
O)
at 37°C
1,50
2,10
Viscosity (mPa.s)
at 20°C
at 37°C
7,2
4,0
18,5
8,9
Density (g/mL)
at 20°C
at 37°C
1,330
1,323
1,418
1,411
pH value
6,0-7,0
6,0-7,0
Pharmacokinetic properties
Distribution
Plasma protein binding following intravenous injection amounts to less than 10%.
A concentratio
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