Dhaval Rathod, Zhengming Chen, Christine M Slover, Frank Kung, Junichi Morita, Sean T Nguyen
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Connection security between empty vials and the VIAL-MATE Adaptor was assessed in triplicate. <b>Results:</b> All predefined physical compatibility criteria between cefiderocol 1 g vials and the MINI-BAG Plus Container System were met, including a secure connection, successful multiple transfers of solution between vial and bag, successful reconstitution of cefiderocol, and lack of leaking into the vial or from the connections. There was no particulate matter in the prepared solution and no precipitation or discoloration. 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引用次数: 1
摘要
背景:需要具有成本效益和方便的方式来促进医院和门诊环境中的抗生素管理。目的:研究MINI-BAG Plus容器系统和VIAL-MATE适配器与头孢地罗1g制剂瓶的物理相容性。方法:采用MINI-BAG Plus容器系统(50、100 mL 5%葡萄糖注射液或0.9%氯化钠注射液),用空瓶和装头孢地罗干粉的小瓶进行定性检测,一式三份,在MINI-BAG上悬挂观察3小时。空瓶与VIAL-MATE适配器之间的连接安全性进行了三次评估。结果:cefiderocol 1g瓶与MINI-BAG Plus容器系统之间的所有预先定义的物理兼容性标准均得到满足,包括安全连接、溶液在瓶和袋之间成功多次转移、cefiderocol成功重构、没有泄漏到瓶中或从连接处泄漏。制备的溶液中无颗粒物质,无沉淀、无变色。演示了VIAL-MATE适配器和cefiderocol小瓶之间的安全连接。结论和相关性:即使在资源有限的地方,使用这些系统也是相关的,并且可能提高医院、门诊机构或长期医疗机构头孢地罗给药的效率。
Cefiderocol For Injection: Compatibility Testing Using the MINI-BAG Plus Container System and the VIAL-MATE Adaptor.
Background: Cost-effective and convenient modalities are required to facilitate the administration of antibiotics in hospital and outpatient settings. Objective: This study investigated the physical compatibility of the MINI-BAG Plus Container System and VIAL-MATE Adaptor with the 1 g drug product vials used for cefiderocol. Methods: Qualitative testing of the MINI-BAG Plus Container System (50 and 100 mL of 5% dextrose injection or 0.9% sodium chloride injection), using empty vials and vials containing lyophilized cefiderocol powder, was conducted in triplicate on MINI-BAGs that were hung and observed over 3 hours. Connection security between empty vials and the VIAL-MATE Adaptor was assessed in triplicate. Results: All predefined physical compatibility criteria between cefiderocol 1 g vials and the MINI-BAG Plus Container System were met, including a secure connection, successful multiple transfers of solution between vial and bag, successful reconstitution of cefiderocol, and lack of leaking into the vial or from the connections. There was no particulate matter in the prepared solution and no precipitation or discoloration. Secure connections between the VIAL-MATE Adaptor and cefiderocol vials were demonstrated. Conclusion and Relevance: Use of these systems is relevant even where resources are limited and may increase the efficiency of cefiderocol administration in hospitals, outpatient settings, or long-term healthcare facilities.
期刊介绍:
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