Maa: Etelä-Afrikka
Kieli: englanti
Lähde: South African Health Products Regulatory Authority (SAHPRA)
Schering
ISOVIST 240 10 mL ISOVIST 240 20 mL SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): ISOVIST 240 10 mL ISOVIST 240 20 mL Non-ionic contrast medium solutions COMPOSITION 1 mL Isovist 240 contains iotrolan (5,5-(N,N'-dimethylmalonyldiimino)-bis-[2,4,6-triiodo-isophthalic acid-bis-(2,3- dihydroxy-1-hydroxymethylpropyl)-diamide]) 512,59 mg in aqueous solution. Iodine concentration (mg/mL) 240 Iodine content (g) per bottle of 10 mL bottle of 20 mL 2,4 4,8 Contrast medium concentration (mg/mL) 512,59 Contrast medium content (g) per bottle of 10 mL bottle of 20 mL 5,13 10,26 Osmolality at 37°C (osm/kg H 2 O) 0,27 Osmotic pressure at 37°C (MPa) (atm) 0,70 7,0 Viscosity (mPa.s or cP) at 20°C at 37°C 6,8 3,9 PHARMACOLOGICAL CLASSIFICATION A. 28 Contrast media. PHARMACOLOGICAL ACTION Following lumbar injection of 10 mL Isovist 240 in patients who were kept in the sitting position, maximum levels of contrast medium in the blood (6-8% of the dose in total plasma volume) were reached 1 hour post injection in most cases. Iotrolan from the subarachnoid space entered the blood stream with an average half-life of 3,6 hours (median of 9 patients), the range being 2,5-5,9 hours. Renal excretion of iotrolan following lumber injection was 32% of the dose by 6 hours, 80% by 24 hours and 90% by 72 hours post injection. Only about 0,5% of the dose was found in the faeces up to 72 hours post injection. INDICATIONS Radiculography; lumbar myelography in Lue koko asiakirja