Eklira Genuair

Eklira Genuair Use In Pregnancy & Lactation

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: There are no data available on the use of aclidinium bromide in pregnant women.
Studies in animals have shown fetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium bromide (see Pharmacology: Toxicology: Preclinical safety data under Actions). Aclidinium bromide should only be used during pregnancy if the expected benefits outweigh the potential risks.
Breast-feeding: It is unknown whether aclidinium bromide / metabolites are excreted in human milk. Animal studies have shown excretion of small amounts of aclidinium bromide / metabolites into milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Eklira Genuair therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide (see Pharmacology: Toxicology: Preclinical safety data under Actions). It is considered unlikely that aclidinium bromide administered at the recommended dose will affect fertility in humans.
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