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The safety of fibrin sealants/hemostatics for use in human pregnancy or breastfeeding 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, the product should be administered to pregnant and lactating women only if clearly needed.
See Precautions for information on Parvovirus B19 infection.
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