1. Animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. The benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. This drug has been shown to be teratogenic (or to have an embryocidal effect or other adverse effect) in experimental animals when given in certain doses. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
2. There are no animal reproduction studies and no adequate and well controlled studies in humans. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.
Ausreichende Erfahrungen über die Anwendung beim Menschen liegen nicht vor. Der Tierversuch erbrachte Hinweise auf embryotoxische/teratogene Wirkungen.
Insufficient data are available on use in humans. Indications of embryotoxic/teratogenic effects were observed in animal experiments.