The safety of Human Albumin 200 g/l [Baxter/Baxalta] 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.
The effects of human albumin on fertility have not been established in controlled clinical trials.
No animal reproduction studies have been conducted with Human Albumin 200 g/l [Baxter/Baxalta].
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.
However, human albumin is a nor mal constituent of human blood.