XENETIX Solution for injection Ref.[8834] Active ingredients: Iobitriol

After intravascular injection, iobitridol is distributed in the intravascular system and interstitial compartment. In humans, the elimination half-life is 1.8 h, the volume of distribution is 200 ml/kg and the total clearance is 93 ml/min (mean values). Binding to plasma proteins is negligible (<2%). It is mainly eliminated via the kidneys (glomerular filtration without tubular reabsorption or secretion) in unchanged form. The osmotic diuresis induced by Xenetix is dependent on the osmolality and the volume injected.

In patients with renal insufficiency, elimination occurs mainly via the biliary route. The substance can be dialysed.

Toxicological results for intravenous use show an absence of effects, or effects occurring under conditions much more extreme than those recommended for clinical use (dosage, repeated doses). Following the single administration of high doses (9 to 18 gI/kg), Xenetix caused transient signs of hypothermia, respiratory depression and dose-dependent histological lesions that occurred in the target organs (liver, kidney) and included hepatocellular vacuolisation, and tubular vacuolisation and dilation. Following repeated administration of high doses (2.8 gI/kg) for 28 days in dogs, granular vacuolar degeneration that was reversible after discontinuation of treatment was observed.

Local irritation could be observed in the event of extravasation.

Animal studies did not demonstrate any teratogenic effects.