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Pregnancy: Clinical data of CILANEM on pregnancy are very limited, Animal studies are insufficient to draw conclusion for pregnancy, embryonal/foetal development, parturition or postnatal development.
The potential risk for human is unknown. CILANEM should not be used during pregnancy unless clearly necessary.
Lactation: It is not known whether CILANEM is excreted in human breast milk. A study in rats has shown that CILANEM and its metabolite are transferred to milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with CILANEM should be made taking into account the benefit of breastfeeding to the child and the benefit of CILANEM therapy to the woman.
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