Pregnancy & Lactation : הריון/הנקה

4.6      FERTILITY, PREGNANCY AND LACTATION
There is no experience with or evidence of safety of propellant HFA-134a in human pregnancy or lactation. However studies of the effect of HFA-134a on reproductive function and embryofetal development in animals have revealed no clinically relevant adverse effects.

Pregnancy

There are no relevant clinical data on the use of Foster 100/6 in pregnant women. Animal studies using beclometasone dipropionate and formoterol combination showed evidence of toxicity to reproduction after high systemic exposure (see 5.3 Preclinical safety data). Because of the tocolytic actions of beta2- sympathomimetic agents particular care should be exercised in the run up to delivery. Formoterol should not be recommended for use during pregnancy and particularly at the end of pregnancy or during labour unless there is no other (safer) established alternative.
Foster 100/6 should only be used during pregnancy if the expected benefits outweigh the potential risks.


Lactation
There are no relevant clinical data on the use of Foster 100/6 in lactation in humans.
Although no data from animal experiments are available, it is reasonable to assume that beclometasone dipropionate is secreted in milk, like other corticosteroids.
While it is not known whether formoterol passes into human breast milk, it has been detected in the milk of lactating animals.
Administration of Foster 100/6 to women who are breast-feeding should only be considered if the expected benefits outweigh the potential risks.