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Use in Pregnancy (Category B2): The safety of TachoSil for use in human pregnancy has not been established in controlled clinical trials. Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or fetus, the course of gestation and peri- and postnatal development. Therefore, TachoSil should be administered to pregnant women only if the anticipated benefits outweigh the risks.
Use in Lactation: It is not known whether this drug is excreted in human milk. Therefore, TachoSil should be administered to lactating women only if the anticipated benefits outweigh the risks.
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