Страна: Южна Африка
Език: английски
Източник: South African Health Products Regulatory Authority (SAHPRA)
Schering
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 Прочетете целия документ