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This product should not be administered to pregnant women or women who may be pregnant. [The safety of this product in pregnant women has not been established. In an animal study in rats, administration in the perinatal and lactation periods (1 mg/kg and above) resulted in death of dams before or after childbirth in a certain perinatal stage. In an organogenesis period administration study in rabbits (0.3 mg/kg and above), death of dams was observed. Fetal skeletal anomalies were found when a large dose of an HMG-CoA reductase inhibitor was administered to rats. In humans, occurrence of congenital anomalies of the fetus was reported when an HMG-CoA reductase inhibitor was administered up to 3 months during pregnancy.]
This product should not be administered to lactating women. [Animal studies (rats) have shown that this product is excreted in breast milk.]
