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zqxia2009

铁杆木虫 (正式写手)

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[交流] FDA说明书翻译

Pregnancy
Pregnancy Category B: Memantine given orally to pregnant rats and pregnant rabbits
during the period of organogenesis was not teratogenic up to the highest doses tested (18
mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively,
the maximum recommended human dose [MRHD] on a mg/m2 basis).
Slight maternal toxicity, decreased pup weights and an increased incidence of nonossified
cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which
rats were given oral memantine beginning pre-mating and continuing through the postpartum
period. Slight maternal toxicity and decreased pup weights were also seen at this
dose in a study in which rats were treated from day 15 of gestation through the postpartum
period. The no-effect dose for these effects was 6 mg/kg, which is 3 times the
MRHD on a mg/m2 basis.

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