Gadoteridol 0.5mmol/ml solution for injection 15ml vials

Gadolinium-based contrast agents (GBCAs) cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive. Because of the potential risks of gadolinium to the fetus, use gadoteridol only if imaging is essential during pregnancy and cannot be delayed.
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In animal reproduction studies in rats, gadoteridol doubled the incidence of post-implantation loss at up to 16 times the recommended human dose (RHD).

There were no adverse developmental effects observed in rabbits with intravenous administration of gadoteridol during organogenesis at doses up to 19 times the recommended human dose of 0.1 mmol/kg.
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Clinical consequences of overdose with gadoteridol have not been reported. The safety of gadoteridol has been tested in clinical studies using doses up to 0.3 mmol/kg and no clinical consequences related to increasing dose have been observed to date. Gadoteridol can be removed by hemodialysis.
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No animal studies have been performed to evaluate the carcinogenic potential of gadoteridol.
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No changes in reproductive performance and outcome of pregnancy were caused in rats and rabbits by daily intravenous administration of gadoteridol to parent animals before and during gestation up to 1.5 mmol/kg/day (15 times the recommended human dose).
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Gadoteridol did not demonstrate genotoxic activity in: bacterial reverse mutation assays using Salmonella typhimurium and Escherichia coli; a mouse lymphoma forward mutation assay; an in vitro cytogenetic assay measuring chromosomal aberration frequencies in Chinese hamster ovary cells; and an in vivo mouse micronucleus assay at intravenous doses up to 5.0 mmol/kg.
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