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.
Bei umfangreicher Anwendung am Menschen ergab sich kein Verdacht auf eine embryotoxische/teratogene Wirkung. Der Tierversuch erbrachte jedoch Hinweise auf embryotoxische/teratogene Wirkungen. Diese scheinen für den Menschen ohne Bedeutung zu sein.
There was no suspicion of embryotoxic/teratogenic effects after extensive use in humans. Indications of embryotoxic/teratogenic effects were observed in animal experiments. These appear to bear no significance for humans.