Gadodiamide 0.5mmol/ml solution for injection 5ml vials

GBCAs cross the human 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. In animal reproduction studies, no adverse fetal effects were observed with the administration of gadodiamide to pregnant rats during organogenesis at doses 1.3 times the maximum human dose based on body surface area.

Because of the potential risks of gadolinium to the fetus, use gadodiamide only if imaging is essential during pregnancy and cannot be delayed.
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Clinical consequences of overdose with gadodiamide have not been reported. The minimum lethal dose of intravenously administered gadodiamide in rats and mice is greater than 20 mmol/kg (200 times the recommended human dose of 0.1 mmol/kg; 67 times the cumulative 0.3 mmol/kg dose). Gadodiamide is dialyzable.
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Long-term animal studies have not been performed to evaluate the carcinogenic potential of gadodiamide.

The results of the following genotoxicity assays were negative: in vitro bacterial reverse mutation assay, in vitro Chinese Hamster Ovary (CHO)/Hypoxanthine Guanine Phosphoribosyl Transferase (HGPT) forward mutation assay, in vitro CHO chromosome aberration assay, and the in vivo mouse micronucleus assay at intravenous doses of 27 mmol/kg (approximately 7 times the maximum human dose based on a body surface area comparison). Impairment of male or female fertility was not observed in rats after intravenous administration three times per week at the maximum dose tested of 1.0 mmol/kg (approximately 0.5 times the maximum human dose based on a body surface area comparison).
[L49881]