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Pharmacotherapeutic Group: Dye for vascular marking. ATC Code: V04CX.
Pharmacology: Pharmacokinetics: The dye is eliminated in 24 to 48 hours, mainly in urine (which is highly coloured).
Toxicology: Preclinical Safety Data: Preclinical data derived from conventional single-dose and repeated-dose safety pharmacology and toxicology studies have not revealed any particular risk for humans.
A mutagenic effect was observed in vitro, at high concentrations, on a bacterial gene mutation test after metabolic activation. This effect was not confirmed on an in vitro gene mutation test on human mammalian cells (L5178Y murine lymphoma cells), or on a micronucleus test in rats by intravenous injection of doses significantly higher than the maximum dose in humans, and therefore has limited clinical significance.
