Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation
TOBI should not be used during pregnancy or lactation unless the benefits to the mother outweigh the risks to the foetus or baby.

Pregnancy

There are no adequate data from the use of tobramycin administered by inhalation in pregnant women. Animal studies do not indicate a teratogenic effect of tobramycin (see 5.3 Preclinical data). However, aminoglycosides can cause foetal harm (e.g., congenital deafness) when high systemic concentrations are achieved in a pregnant woman. If TOBI is used during pregnancy, or if the patient becomes pregnant while taking TOBI, she should be informed of the potential hazard to the foetus.
Breast-feeding

Systemic tobramycin is excreted in breast milk. It is not known if administration of TOBI will result in serum concentrations high enough for tobramycin to be detected in breast milk.
Because of the potential for ototoxicity and nephrotoxicity with tobramycin in infants, a decision should be made whether to terminate nursing or discontinue TOBI therapy.

Fertility

No effect on male or female fertility was observed in animal studies after subcutaneous administration (see section 5.3).