Pregnancy

There are no adequate and well-controlled studies in pregnant women. Animal studies did not provide any evidence of teratogenic or other embryotoxic effects of aprotinin.

Aprotinin should be used throughout pregnancy only if the potential benefit justifies the potential risk. In case of severe adverse drug reactions (like anaphylactic reaction, heart arrest, etc.) and their consecutive therapeutic measures, damage to the foetus has to be taken into account for a risk/benefit evaluation.

Nursing Mothers

It is unknown whether aprotinin is excreted in human milk. However, since aprotinin is not bioavailable after oral administration, any drug contained in the milk is not expected to have a systemic effect on the breast-feed child.

Carcinogenesis, Mutagenesis and Fertility

Fertility

There are no adequate and well-controlled studies addressing fertility in men or women.

Effects on Ability to Drive and Use Machines

Not relevant.