Đăng xuất
The effect on pregnancy and lactation has not been investigated in humans. Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rats at maternotoxic doses.
OPRYMEA should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the fetus. As pramipexole treatment inhibits the secretion of prolactin in humans, inhibition of lactation is expected. The excretion of pramipexole into breast milk has not been studied in women. In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
In the absence of human data, OPRYMEA should not be used during breast-feeding. However, if its use is unavoidable, breastfeeding should be discontinued.
No studies on the effect on human fertility have been conducted. These studies did not indicate direct or indirect harmful effects with respect to male fertility.
