通用名称

dolutegravir

儿科标签批准日期

2020/6/12 0:00:00

特定指示/秒

HIV-1 infection in pediatric patients at least 4 weeks old and weighing at least 3 kg

标签更改摘要

- Tivicay PD tablets for oral suspension approved in pediatric patients at least 4 weeks old and weighing at least 3 kg. - The dosage of Tivicay PD tablets for oral suspension in pediatric patients weighing 3 to 14 kg is weight-based. - Safety and effectiveness of Tivicay and Tivicay PD have not been established in pediatric patients less than 4 weeks or weighing less than 3 kg or in any pediatric patients who are integrase strand transfer inhibitor (INSTI)-experienced with documented or clinically suspected resistance to other INSTIs. - Do not use Tivicay tablets in patients weighing 3 to 14 kg. - Safety profile is similar to those observed in adults. - Information on dosing, adverse reactions, PK parameters, and clinical studies - Postmarketing study. - New dosage form.

治疗类别

Antivirals

立法类型

PREA + BPCA

产品说明书链接

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