The safety of Human Albumin 20% Behring, low salt, for use in human pregnancy has not been
established in controlled clinical trials. However, clinical experience with albumin suggests that
no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected,
particularly since human albumin is a normal constituent of human blood. No animal
reproduction studies have been conducted with Human Albumin 20 % Behring, low salt.
Experimental animal studies are insufficient to assess the safety with respect to reproduction,
development of the embryo or foetus, the course of gestation and peri- and postnatal development.