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Pregnancy: There are no or limited amount of data from the use of Elthropa in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Elthropa is not recommended during pregnancy.
Women of childbearing potential/Contraception in males and females: Elthropa is not recommended in women of childbearing potential not using contraception.
Breast-feeding: It is not known whether Elthropa/metabolites are excreted in human milk. Studies in animals have shown that Elthropa is likely secreted into milk; therefore a risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to continue/abstain from Elthropa therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Fertility was not affected in male or female rats at exposures that were comparable to those in humans. However a risk for humans cannot be ruled out.
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