The effects of Prothromplex TOTAL 600 IU on fertility have not been established in controlled clinical trials.
The safety of human prothrombin complex for use in human pregnancy and during lactation has not been established. There are no adequate data from the use of Prothromplex TOTAL 600 IU in pregnant or lactating women.
Animal studies are not suitable to assess the safety with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Therefore, Prothromplex TOTAL 600 IU should be used during pregnancy and lactation only if clearly indicated.
See Precautions for information on the risk of Parvovirus B19 infection in pregnant women.