Страна: ЮАР
Язык: английский
Источник: South African Health Products Regulatory Authority (SAHPRA)
Schering
INDICATIONS [/za_1139.html#1] [/za_1139.html#1] [/za_1139.html#1] CONTRA-INDICATIONS [/za_1139.html#1] [/za_1139.html#1] DOSAGE [/za_1139.html#1] [/za_1139.html#1] SIDE-EFFECTS [/za_1139.html#1] [/za_1139.html#1] [/za_1139.html#1] PREGNANCY [/za_1139.html#1] [/za_1139.html#1] OVERDOSE [/za_1139.html#1] IDENTIFICATION [/za_1139.html#1] [/za_1139.html#1] PATIENT INFORMATION GADOVIST SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): GADOVIST 7,5 ML, 10 ML, 15 ML, 30 ML, 65 ML Paramagnetic contrast medium solution for magnetic resonance imaging COMPOSITION 1 mL of the neutral paramagnetic contrast agent for magnetic resonance imaging contains GADOBUTROL (10- [(1SR,2RS)-2,3-dihydroxy-1-hydroxy-methylpropyl]-1,4,7,10-tetraazacyclo-dodecane-1,4,7-triacetic acid, gadolinium- complex) 604,72 mg (equivalent 1,0 mmol) as active ingredient, as well as 0,513 mg calcobutrol sodium, 1,211 mg trometamol, hydrochloric acid and water for injection as inactive ingredients. PHYSICO-CHEMICAL PROPERTIES Contrast medium concentration (mg/mL) (mmol/mL) 604,72 1,0 Osmolarity at 37°C (mOsm/L solution) 1117 Osmolality at 37°C (mOsm/kg H 2 O) 1603 Viscosity at 37°C (mPa·s) 4,96 pH 7,0 –7,4 PHARMACOLOGICAL CLASSIFICATION A. 28 Contrast media. PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Gadovist is a paramagnetic contrast agent for magnetic resonance imaging. The contrast-enhancing effect is mediated by gadobutrol, the neutral complex consisting of gadolinium (III) and the macrocyclic dihydroxy-hydroxymethylpropyl- tetraazacyclododecane-triacetic acid (butrol). In T 2 *-weighted gradient echo sequence the induction of local magnetic field fluctuations by the large magnetic moment of gadolinium leads to a signal decrease of tissues in such sequence Прочитать полный документ