Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation

Pregnancy:
The safety of Kopaq for use in human pregnancy has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development.
Since whenever possible, radiation exposure should be avoided during pregnancy, the benefits of an X-ray examination, with or without contrast media, should be carefully weighed against the possible risk. Kopaq should not be used in pregnancy unless the benefit outweighs risk, and it is considered essential by the physician.

Apart from avoidance of exposition to radiation, the sensitivity of the foetal thyroid gland to iodine should be taken into account when risk and benefit are evaluated.

In neonates who have been exposed to iodinated contrast media in utero, it is recommended to monitor thyroid function (see section 4.4).

Breast-feeding:
Contrast media are poorly excreted in human breast milk and minimal amounts are absorbed by the intestine. Harm to the nursing infant is therefore unlikely. Breast feeding may be continued normally when iodinated contrast media are given to the mother. The amount of iohexol in breast milk excreted in 24 hours after injection was 0.5% of the weight adjusted dose in a trial.

The amount of iohexol ingested by the baby in the first 24 hours after injection corresponds to only 0.2% of the paediatric dose.