Pregnancy: Adequate and well controlled studies in pregnant women have not been conducted.
GBCAs cross the placenta and result in foetal exposure and gadolinium retention. Human data on the association between GBCA and adverse foetal outcomes are limited and inconclusive. OMNISCAN should therefore only be used during pregnancy if the potential benefit justifies the potential risk to the foetus and the pregnant woman.
Breast-feeding: The degree of excretion into human milk is not known.
Available data in animals have shown excretion of gadodiamide in milk. A risk to the suckling child cannot be excluded.
Fertility: There are no clinical data available with regard to effects on fertility.
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