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Pharmacology: Toxicology: In embryonic and fetal toxicity study of rat and animal test performed with rat and marmoset for 13 weeks, there was no toxicological finding which may be considered meaningful in human.
As a result of oral administration in rat for 13 weeks, proventricular inflammation was observed in male administered with over 3/48mg/kg/day but not observed in female rat. These results were not found in any doses of marmoset but colitis was observed upon high dose administration (No influence was found in less than 5/80mg/kg/day). Occurrence of gastrointestinal system adverse reaction observed on drug administration was similar with that observed on single administration in clinical studies.
