Pregnancy & Lactation : הריון/הנקה

4.6      Fertility, pregnancy and lactation

Fertility
There are no data in humans. In animal studies in rats, the presence of beclometasone dipropionate at high doses in the combination was associated with reduced female fertility and embryotoxicity (see section 5.3).

Pregnancy
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.

There are no relevant clinical data on the use of Foster 200/6 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 200/6 should only be used during pregnancy if the expected benefits outweigh the potential risks.

Lactation (Breast feeding)
There are no relevant clinical data on the use of Foster 200/6 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 200/6 to women who are breast-feeding should only be considered if the expected benefits outweigh the potential risks.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Foster 200/6 therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.