Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1.   Pharmacodynamic properties
Pharmacotherapeutic group: IODINATED CONTRAST AGENT
ATC code: V08AB11
XENETIX 250 is a urographic and angiographic water-soluble nonionic contrast agent with an osmolality of 585 mOsm/kg.
XENETIX 300 is a urographic and angiographic water-soluble nonionic contrast agent with an osmolality of 695 mOsm/kg.
XENETIX 350 is a urographic and angiographic water-soluble nonionic contrast agent with an osmolality of 915 mOsm/kg.

The iobitridol molecule exhibits a stable and balanced hydrophilic character.
The evaluation of overall safety with respect to the hemodynamic, cardiovascular, bronchopulmonary, renal, neurological, vascular and rheological systems has shown that the safety profile of iobitridol is the same as that of other non-ionic water-soluble tri-iodinated lowosmolality contrast media, particularly in cardiovascular or neurological terms, or comparable to that of a reference solution.

Pharmacokinetic Properties

5.2.   Pharmacokinetic properties
Injected via the intravascular route, iobitridol is distributed through the vascular system and interstitial space. In humans, the elimination half-life is 1.8 h, the distribution volume is 200 mL/kg and the total clearance is 93 mL/min on average. Binding to plasma proteins is low (< 2%). It is mainly eliminated by the kidneys (glomerular filtration without reabsorption or secretion at tubule level) in unchanged form.
The osmotic diuresis induced by XENETIX is related to the osmolality and the volume injected.
In the event of renal insufficiency, elimination is mainly by biliary route. The substance is dialysable.