Iobitriol

In the interview and with appropriate tests, systemically check for possible pregnancy in women of childbearing age. Exposure of the female genital routes to x-rays must be subjected to careful evaluation of the benefit-to-risk ratio.

Hysterosalpingography with iobitridol during pregnancy is contraindicated.

Embryotoxicity

Animal studies have not shown any teratogenic effects.

In the absence of any teratogenic effects in animal species, no malformative effect is expected in humans. To date, substances causing malformations in humans have always proved to be teratogenic in animals during studies properly conducted in two species.

Foetotoxicity

The transient iodine overload following administration to the mother may induce foetal dysthyroidism if the examination takes place after more than 14 weeks of amenorrhoea. However, in view of the reversibility of the effect and expected benefit to the mother, the isolated administration of an iodinated contrast agent is justifiable if the indication for the radiological examination in a pregnant woman has been carefully evaluated.

Iodinated contrast agents are only excreted in breast milk in very small amounts. Isolated administration to the mother consequently involves a minor risk of adverse reactions in the infant. It is advisable to stop breastfeeding for 24 hours after administration of the iodinated contrast agent.

Mutagenicity and fertility

The product was not found to be mutagenic under the test conditions used. No data on reproductive function are available.

No particular risks are known.