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首页> 外文期刊>Reproductive toxicology >Reproduction and juvenile animal toxicology studies in the rat with a new allergy vaccine adjuvanted with monophosphoryl lipid A (MPL((R))) for the treatment of grass pollen allergy.
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Reproduction and juvenile animal toxicology studies in the rat with a new allergy vaccine adjuvanted with monophosphoryl lipid A (MPL((R))) for the treatment of grass pollen allergy.

机译：用一种新的变态反应疫苗与单磷酰脂质A（MPL（R））结合治疗草花粉变态反应，在大鼠中进行生殖和少年动物毒理学研究。

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Pollinex((R)) Quattro Grass has been developed for the prevention or relief of allergic symptoms caused by pollen in both adults and children. Reproduction and juvenile animal toxicology studies have been performed. Subcutaneous injection on Day 14 prior to pairing and on Days 6 and 13 of gestation to pregnant rats at 2000SU/0.5 mL elicited no signs of maternal or embryo-foetal toxicity. Mating, fertility, fecundity and pup parameters were all unaffected by treatment. Once-weekly subcutaneous administration at ascending doses of 300, 800, 2000 and 2000SU/0.5 mL followed by a 4 week non-dose period to juvenile rats from 3 weeks of age showed no signs of obvious toxicity. As in a previously performed adult animal toxicology study with the vaccine, not unexpected, but relatively minor, immuno-stimulatory effects were seen in this study along with injection site reaction which can largely be attributed to the presence of tyrosine in the formulation.
机译：已开发出用于预防或缓解成人和儿童中由花粉引起的过敏症状的Pollinex Quattro Grass。已经进行了生殖和少年动物毒理学研究。配对前第14天以及妊娠第6天和第13天以2000SU / 0.5 mL皮下注射给怀孕大鼠，没有引起母体或胚胎-胎儿毒性的迹象。交配，生育力，繁殖力和幼仔参数均不受治疗的影响。每周一次以300、800、2000和2000SU / 0.5 mL的递增剂量皮下给药，然后从3周龄开始对幼年大鼠进行为期4周的非给药，没有明显的毒性迹象。如同先前使用疫苗进行的成年动物毒理学研究一样，在这项研究中观察到并非意外的但相对较小的免疫刺激作用以及注射部位反应，这在很大程度上可归因于制剂中存在酪氨酸。

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