通用名称

insulin aspart

儿科标签批准日期

2019/12/19 0:00:00

特定指示/秒

Diabetes mellitus in pediatric patients

标签更改摘要

- Safety and effectiveness have been established to improve glycemic control in pediatric patients with diabetes mellitus. - Use for this indication is supported by evidence from an adequate and well-controlled study in 777 pediatric patients with type 1 diabetes mellitus aged 2 to 17 years, and from studies in adults with diabetes mellitus. - Pediatric patients with type 1 diabetes treated with mealtime and postmeal FIASP reported a higher rate of blood glucose confirmed hypoglycemic episodes compared to patients treated with NovoLog; the imbalance was greater during the nocturnal period. - Monitor blood glucose levels closely in pediatric patients. - Information on dosing, adverse reactions, PK parameters and clinical trials. - Postmarketing stud.

治疗类别

Hyperglycemic Agents

立法类型

PREA Only

产品说明书链接

书号

2.0 1.0

研究年龄

2 YEARS - 17 YEARS 6 YEARS - 17 YEARS

学习类型

Efficacy,Safety Pharmacokinetic,Pharmacodynamic

研究设计

Single-Blind,Parallel Group Single-Blind,Trad PK

登记的患者

753 29

患者分析

N/A N/A

中心的数量

150 1

国家数量

17 1

西班牙裔拉美裔/拉丁裔总计

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非西班牙裔/非拉丁裔总人数

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总数#种族不明

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亚裔学生总数

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黑人总数

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白人总数

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夏威夷或太平洋岛民总数

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美洲印第安人/阿拉斯加本地人总数

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其他种族总计

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未知种族总数

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国家

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