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Pregnancy: There are no adequate data on the use of MIRCERA in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing MIRCERA to pregnant women.
Labor and Delivery: No data to report.
Nursing Mothers: It is unknown whether methoxy polyethylene glycol-epoetin beta is excreted in human breast milk. One animal study has shown excretion of methoxy polyethylene glycol-epoetin beta in maternal milk. A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with MIRCERA should be made taking into account the benefit of breastfeeding to the child and the benefit of MIRCERA therapy to the woman.
