Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Guerbet, BP 57400, 95943, Roissy CdG cedex, France
Pharmacotherapeutic group: Watersoluble, nephrotropic, low osmolar X-ray contrast media
ATC code: V08AB07
Optiray 350 is a non-ionic X-ray contrast medium. Intravascular injection of Optiray opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualisation of the internal structures until significant haemodilution occurs.
The pharmacokinetic profile of Optiray, together with its hydrophilic properties and a very low level of binding to serum and plasma proteins, indicate that Optiray is distributed within the extracellular fluid space and eliminated quickly through the kidneys by glomerular filtration. The mean (±se) half-lives after doses of 50 ml and 150 ml were 113 ± 8.4 and 104 ± 15 minutes respectively. Elimination via the faeces is negligible. No significant metabolism, deiodination, or biotransformation of Optiray has been observed.
There were no findings in the preclinical testing of Optiray which could be of relevance for the prescriber in recognising the safety of this product used for the authorised indications, and which are not already included in other sections of the SPC.
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