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Fertility: There are no data on the effects of ANORO ELLIPTA on human fertility. Animal studies indicate no effects of umeclidinium or vilanterol on fertility (see Pharmacology: Toxicology: Non-Clinical Information under Actions).
Pregnancy: There are no or limited amount of data from the use of ANORO ELLIPTA in pregnant women. Studies in animals have shown reproductive toxicity after inhaled administration of vilanterol (see Pharmacology: Toxicology: Non-Clinical Information under Actions). ANORO ELLIPTA should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Lactation: It is unknown whether umeclidinium or vilanterol are excreted in human milk. However, other beta2-agonists are detected in human milk. A risk to breastfed newborns/infants cannot be excluded.
A decision must be made whether to discontinue breastfeeding or to discontinue ANORO ELLIPTA therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
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