达格列净片 FARXIGA (dapagliflozin) FDA药品说明书翻译.pdf

FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 适应症和用途 FARXIGA (dapagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)]. 本药用于配合饮食控制和运动改善2型糖尿病患者的血糖控制。 1.1 Limitation of Use 使用限制 FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. 本药不适用于1型糖尿病或糖尿病酮症酸中毒患者。 2 DOSAGE AND ADMINISTRATION 用法用量 2.1 Recommended Dosing 推荐剂量 The recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning, with or without food. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily. 推荐起始剂量为一次5mg，一日1次，早晨服用，可与或不与食物同服。对本药一次5mg， 一日1次剂量耐受且须更多血糖扩指着，可增至一次10mg，一日1次。 In patients with volume depletion, correcting this condition prior to initiation of FARXIGA is recommended [see Warnings and Precautions (5.1), Use in Specific Populations (8.5, 8.6), and Patient Counseling Information (17)]. 血容量减少患者，推荐用药前应先纠正血容量减少。 2.2 Patients with Renal Impairment 肾功能不全时剂量 Assessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter. 建议在开始使用本药前及使用期间定期评估肾功能。 2 FARXIGA should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m . 肾小球滤过率＜60ml/(min/1.73m2)患者不得开始用药。 2 No dose adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m or greater). 轻度肾功能损害者[肾小球滤过率≥60ml/(min/1.73m2)]无需调整剂量。 2 FARXIGA should be discontinued when eGFR is persistently less than 60 mL/min/1.73 m [see Warnings and