Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, Pregnancy and lactation
Pregnancy:
The safety of VISIPAQUE 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 fetus, the course of gestation and peri- and postnatal development. Since, wherever possible, radiation exposure should be avoided during pregnancy, the benefits of any X-ray examination, with or without contrast media, should be carefully weighed against the possible risk. The product should not be used in pregnancy unless benefit outweighs risk and it is considered essential by the physician.

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. Breast feeding may be continued normally when iodinated contrast media are given to the mother.

Fertility:
The effect of VISIPAQUE on human reproduction has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to reproduction.