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DEVICES AND METHODS FOR DELIVERING OPIOID ANTAGONISTS INCLUDING FORMULATIONS FOR NALOXONE
DEVICES AND METHODS FOR DELIVERING OPIOID ANTAGONISTS INCLUDING FORMULATIONS FOR NALOXONE
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机译：用于提供阿片拮抗剂的制剂和方法，包括纳洛酮制剂
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摘要
An apparatus includes a container, a needle, and an actuation assembly. The container contains a dose of a naloxone composition having a delivered volume of at least about 0.34 mL. The actuation assembly includes an energy storage member that produces a force on a movable member to move the needle and to deliver the dose of the naloxone composition. The 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after dose delivery into the body (Cmax), time to reach the maximum naloxone plasma concentration (Tmax), area under the plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC0-∞), or area under the plasma concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%.
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机译：一种设备，包括容器，针和致动组件。所述容器容纳一定剂量的纳洛酮组合物，所述纳洛酮组合物的递送体积为至少约0.34mL。致动组件包括能量存储部件，该能量存储部件在可移动部件上产生力以移动针头并递送纳洛酮组合物的剂量。剂量释放到体内后，相对平均纳洛酮最大血浆浓度至少之一（C max ）的90％置信区间，达到纳洛酮最大血浆浓度（T max < / Sub>），从剂量前（时间0）外推至无穷大（AUC 0-∞）的血浆浓度-时间曲线下的面积，或从剂量前的血浆浓度-时间曲线下的面积剂量（时间0）到给药剂量至相应纳洛酮组合物给药剂量的最后可量化浓度（T last ）（AUC 0-t ）的时间通过手动注射器输送的药物在80％至125％之间。
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