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Use in pregnancy (Category A†): There are no adequate and well-controlled clinical studies conducted in pregnant or breastfeeding woman. No formal animal reproductive toxicity studies with folinic acid have been conducted. There are no indications that folic acid induces harmful effects if administered during pregnancy.
Fluorouracil use is generally contraindicated during pregnancy and contraindicated during breastfeeding; this applies also to the combined use of folinic acid with fluorouracil.
†Category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without proven increase in frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Use in lactation: It is not known whether this medicine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when folinic acid is administered to a breastfeeding mother.
