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