Страна: ЮАР
Язык: английский
Источник: South African Health Products Regulatory Authority (SAHPRA)
Schering
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 Прочитать полный документ