Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
MAGNEVIST SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): MAGNEVIST MAGNEVIST 5 mL MAGNEVIST 10 mL MAGNEVIST 15 mL MAGNEVIST 20 mL MAGNEVIST 30 mL MAGNEVIST 100 mL Paramagnetic contrast medium for magnetic resonance imaging (MRI) COMPOSITION 1 mL Magnevist contains gadopentetic acid (dihydrogen[N,N-bis[2-[bis(carboxymethyl)-amino]ethyl]-glycinate(5-)] gadolinate (2-), dimeglumine salt 469,01 mg, diethylene triamine pentaacetic acid (DTPA), (3-azapentamethylene diamine-N,N,N',N'-3-pentaacetic acid) meglumine salt, maximum 1,02 mg in aqueous solution. Contrast medium concentration (mg/mL) 469,01 (mol/L) 0,5 Contrast medium content (g) per 5 mL 2,3 10 mL 4,7 15 mL 7,0 20 mL 9,4 30 mL 14,1 100 mL 46,9 Osmolarity at 37°C (osm/L solution) 1,44 Osmolality at 37°C (osm/kg H 2 O) 1,96 Osmotic pressure at 37°C (atm) 49,8 (MPa) 5,06 Density (kg/L) at 20°C 1,210 at 37°C 1,195 Viscosity (mPa.s or cP) at 20°C 4,9 at 37°C 2,9 at 37°C 2,9 pH 6,5-8,0 PHARMACOLOGICAL CLASSIFICATION A. 28 Contrast media. PHARMACOLOGICAL ACTION Magnevist is a paramagnetic contrast medium for use in magnetic resonance imaging (MRI). The contrast enhancing effect is brought about by the di-N-methylglucamine salt of gadopentetate (Gd-DTPA), the gadolinium complex of diethylenetriamine pentaacetic acid. The spin-lattice relaxation time of the excited nuclei, which is shortened Read the complete document