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Pregnancy: Cyproterone acetate + Ethinylestradiol (Diane 35) is not indicated during pregnancy. If pregnancy occurs during treatment with Cyproterone acetate + Ethinylestradiol (Diane 35), further intake must be stopped (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Lactation: The administration of Cyproterone acetate + Ethinylestradiol (Diane 35) is contraindicated during lactation. Cyproterone acetate is transferred into the milk of lactating women. About 0.2 % of the maternal dose will reach the newborn via milk corresponding to a dose of about 1 μg/kg. 0.02 % of the daily maternal dose of ethinylestradiol could be transferred to the newborn via milk during established lactation.
