通用名称

clindamycin injection; clindamycin injection in dextrose

儿科标签批准日期

2020/3/4 0:00:00

特定指示/秒

Postmarketing study

标签更改摘要

- The following statement was added to Dosage and Administration section: Clindamycin should be dosed on total body weight regardless of body weight. - Obese Pediatric Patients Aged 2 to Less than 18 Years and Obese Adults Aged 18 to 20 Years: An analysis of pharmacokinetic data in obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution, normalized by total body weight, are comparable regardless of obesity. - Off-patent Written Request.

治疗类别

Anti-Infective

立法类型

409I(BPCA)

产品说明书链接

书号

1.0

研究年龄

1 DAYS - 16 WEEKS

学习类型

Efficacy,Safety,Pharmacokinetic

研究设计

Multicenter,Open-Label,Population PK,Phase 2,Phase 3,Prospective,Partially Randomized

登记的患者

47

患者分析

46

中心的数量

41

国家数量

2

西班牙裔拉美裔/拉丁裔总计

11

非西班牙裔/非拉丁裔总人数

34

总数#种族不明

1

亚裔学生总数

1

黑人总数

10

白人总数

26

夏威夷或太平洋岛民总数

0

美洲印第安人/阿拉斯加本地人总数

0

其他种族总计

1

未知种族总数

8

国家

United States,Canada