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Zydena is not indicated for use in neonates, pediatrics, or women.
After administration of 300 mg/kg/day to rats and 240 mg/kg/day to rabbits during organogenesis, toxicity such as skeletal variations and delayed ossification of the fetus appeared. In pre- and post-natal development studies and maternal function tests in rats, when administered with 300 mg/kg/day of Zydena, stillbirths or hyposmia occurred.
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