TRAUMEEL® PRODUCT MONOGRAPH60

PREGNANCY AND LACTATION

For this product no clinical data on pregnancy and lactation are available. Homeopathic dilutions of the substances present in this medicinal product are not known to be harmful during pregnancy and lactation. No adverse effects have so far been reported.

Animal reproduction studies have not been performed and the effects of Traumeel® on the unborn fetus are unknown. In pregnancy or suspected pregnancy, Traumeel® should only be used if, in the judgment of the treating physician, the potential benefits outweigh the potential risks to the fetus.

It is not known whether any of the ingredients in Traumeel® are excreted in human milk. Consequently, Traumeel® should be administered with caution to nursing mothers under the close supervision of a physician.

LONG-TERM SAFETY

There is no evidence of tachyphylaxis or addiction following the long-term use of Traumeel®.

No studies have been performed to evaluate the carcinogenicity of Traumeel®, however, in worldwide post-marketing surveillance studies, no evidence of carcinogenicity has been found.