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Pregnancy: Carboplatin proved to be embryotoxic and mutagenic in organogenesis in rats.
No controlled studies have been conducted in pregnant women. PARAPLATIN should therefore not be used during pregnancy. Patients of child-bearing age should use reliable contraceptive measures and must be given advice both in this regard and regarding the risk presented by a pregnancy while they are being treated with PARAPLATIN.
Lactation: It is not known whether carboplatin is secreted into breast milk; during treatment with carboplatin, mothers should not breastfeed.
Fertility: Given the mutagenic potential of PARAPLATIN, an effective contraception is required for both male and female patients during treatment and up to six months after ending treatment. As PARAPLATIN may decrease male fertility, preservation of sperm may be considered for the purpose of later fatherhood (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
