通用名称

glucagon

儿科标签批准日期

2019/7/24 0:00:00

特定指示/秒

Treatment of severe hypoglycemia in patients with diabetes ages 4 years and older

标签更改摘要

- Safety and effectiveness for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients ages 4 years and above. Use for this indication is supported by evidence from a study in 48 pediatric patients from 4 to <17 years of age with type 1 diabetes mellitus. - Safety and effectiveness have not been established in pediatric patients younger than 4 years. - Information on dosing and administration, adverse reactions, clinical trials, and pharmacokinetics and pharmacodynamics. - New dosage form.

治疗类别

Therapies for Hypoglycemia

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

4 YEARS - 16 YEARS

学习类型

Safety,Pharmacokinetic,Pharmacodynamic,Tolerability

研究设计

Single-Blind,Trad PK

登记的患者

48

患者分析

N/A

中心的数量

7

国家数量

1

西班牙裔拉美裔/拉丁裔总计

N/A

非西班牙裔/非拉丁裔总人数

N/A

总数#种族不明

N/A

亚裔学生总数

N/A

黑人总数

N/A

白人总数

N/A

夏威夷或太平洋岛民总数

N/A

美洲印第安人/阿拉斯加本地人总数

N/A

其他种族总计

N/A

未知种族总数

N/A

国家

N/A