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zqxia2009

铁杆木虫 (正式写手)

[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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zqxia2009

铁杆木虫 (正式写手)

是不是嫌给的金币少呀?
3楼2010-04-16 13:11:55
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zqxia2009

铁杆木虫 (正式写手)

怎么没人帮忙呢?
2楼2010-04-16 08:52:20
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lastzealot

新虫 (著名写手)

【乱世的奸雄】

lz还是自己翻译吧
4楼2010-04-16 13:19:53
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gjy9814100

金虫 (正式写手)

zqxia2009(金币+1): 2010-04-17 08:15
孕妇:
B类孕妇:口服给药于婴幼儿器官形成时期的怀孕大鼠和兔子的最高试验剂量美金刚没有致畸作用(大鼠18mg/kg/day和兔子30 mg/kg/day, 这分别是基于mg/m2的最大人体推荐剂量[MRHD] 的9倍和 30 倍)。在18 mg/kg/day 口服剂量的一项研究中,观察到轻微的母体毒性、幼崽体重减轻和非僵化颈椎发生率上升,在这项研究中,大鼠在交配前被口服给药美金刚,并在整个产后期中持续给药。轻微的母体毒性和幼崽体重减轻也在这个剂量组的另一项研究中被观察到,在本项研究中,大鼠从妊娠的第15天和整个产后期被给药处理。对于这些影响无效应剂量为6 mg/kg, 相当于基于mg/m2的最大人体推荐剂量[MRHD] 的3倍.
5楼2010-04-16 13:42:50
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