通用名称

bupivacaine liposome

儿科标签批准日期

2021/3/22 0:00:00

特定指示/秒

Postsurgical local anesthesia in pediatric patients 6 years and older

标签更改摘要

- Safety and effectiveness for single-dose infiltration to produce postsurgical local anesthesia have been established in pediatric patients aged 6 years and older. - Use for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 6 years and older - Safety and effectiveness have not been established in pediatric patients aged less than 6 years old for local infiltration or less than 18 years old for interscalene brachial plexus nerve block. - Information on dosing, adverse reactions, and clinical trial. - Postmarketing study.

治疗类别

Perioperative Analgesia

立法类型

PREA Only

产品说明书链接

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