No abnormality was observed in the animal (rats) reproduction studies, where BCG was administered to rats prior or early stages of pregnancy. The influence of Immunobladder on the later stages of pregnancy and on fetus has not been confirmed. Further, intravesical instillation of Immunobladder may cause problems in maintaining pregnancy. Immunobladder should not be administered to a pregnant woman or woman suspected of being pregnant.
Women who might become pregnant should be advised not to become pregnant while on therapy with Immunobladder.
It is not known whether Immunobladder is excreted in human milk when instilled into urinary bladder. If it is excreted as many drugs, there is potential risk for serious adverse reactions from Immunobladder in nursing infants, so, a decision should be made whether to discontinue nursing or to discontinue intravesical instillation of Immunobladder, taking into account the importance of the instillation-therapy to the mother.