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Pregnancy, delivery or lactation: GOOFICE should be used in pregnant women and women who may possibly be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. [The influences of a high dose oral administration of drug in animal studies (in rats) were observed in maternal toxicity (1000 mg/kg/day) and survival, growth and development of offspring (350 mg/kg/day and higher).]
It is advised that lactating women should avoid GOOFICE. If treatment with GOOFICE is essential, breast feeding must be discontinued during treatment. [In an animal experiment (in rats) using 14C-elobixibat, transfer of radioactivity into milk has been reported.]
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