The safety of human albumin for use in human pregnancy has not been determined by means of controlled clinical trials.
Experimental animal studies are insufficient to assess the safely with respect to reproduction, development of the embryo or foetus, course of gestation and peri and postnatal development.
However, human albumin is a normal constituent of human blood, therefore albumin may be used, if clearly needed, during pregnancy and lactation. However, in general, particular attention must be paid when a substitution of volume is affected in a pregnant patient.
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