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1、FULL PRESCRIBING INFORMATION1 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 reco
2、mmended 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 tol
3、erating 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, 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 recommend
4、ed 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.
5、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v 60ml/(min/1.73m 2)患者不得开始用药。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。2FARXIGA s
6、hould be discontinued when eGFR is persistently less than 60 mL/min/1.73 m see Warnings and Precautions (5.2) and Use in Specific Populations (8.6) .肾小球滤过率持续v 60ml/(min/1.73m 2)时应停药。 l ”5” engrav3 DOSAGE FORMS AND STRENGTHS 剂型和规格FARXIGA 5 mg tablets are yellow, biconvex, round, film-coated tablets w
7、ith one side and “1427” engraved on the other side.FARXIGA 10 mg tablets are yellow, biconvex, diamond-shaped, film-coated tablets with engraved on one side and“1428” engraved on the other side.达格列净片 (1)5mg 。 (2)10mg。4 CONTRAINDICATIONS 禁忌症History of a serious hypersensitivity reaction to FARXIGA se
8、e Adverse Reactions (6.1).Severe renal impairment, end-stage renal disease (ESRD), or patients on dialysis see Use in Specific Populations (8.6) .1. 对本药有严重过敏史者。2. 重度肾功能损害、晚期肾病患者。3. 透析患者。5 WARNINGS AND PRECAUTIONS 警告和注意事项5.1 Hypotension 低血压FARXIGA causes intravascular volume contraction. Symptomatic
9、hypotension can occur after initiating FARXIGA see Adverse Reactions (6.1) particularly in patients with impaired renal2function (eGFR less than 60 mL/min/1.73 m ), elderly patients, or patients on loop diuretics. Before initiating FARXIGA in patients with one or more of these characteristics, volum
10、e status should be assessed and corrected. Monitor for signs and symptoms of hypotension after initiating therapy. 本药可引起血管收缩，开始用药后可出现症状性低血压。尤其肾功能损害者 ( 肾小球滤过率 v 60ml/(min/1.73m 2)、老年患者、使用髓袢利尿药的患者。 以上患者开始使用本药前应先评 估并纠正血容量状况。用药后应监测低血压迹象和症状。5.2 Impairment in Renal Function 肾功能损害FARXIGA increases serum cr
11、eatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Adverse reactions related to renal function can occur after initiating FARXIGA see Adverse Reactions (6.1). Renal function should be evaluated prior to initiation of FARX
12、IGA and monitored periodically thereafter 本药可增加血清肌酸酐并降低肾小球滤过率。 老年患者和肾功能损害者对此类作用更为敏感。 用药后可能出现与肾功能相关的不良反应，开始使用本药前及使用期间应定期评估肾功能。5.3 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues 低血糖(与 胰岛素和胰岛素促泌剂合用时 )Insulin and insulin secretagogues are known to cause hypoglycemia. FARXIGA ca
13、n increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue see Adverse Reactions (6.1). Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when these agents are used in combination with FARXIGA. 已知胰岛素和胰岛素促泌剂可
14、引起低血糖。 本药与以上两种药物合用时发生低血糖的风险增 加。合用时可能需降低胰岛素或胰岛素促泌剂的剂量，以降低低血糖风险。5.4 Genital Mycotic Infections 生殖器霉菌感染FARXIGA increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections see Adverse Reactions (6.1). Moni
15、tor and treat appropriately.本药增加发生生殖器霉菌感染的风险。 有生殖器霉菌感染病史的患者更易出现。 应进行适当 的监测和治疗。5.5 Increases in Low-Density Lipoprotein Cholesterol (LDL-C) 低密度脂蛋白 (LDL-C) 升高 Increases in LDL-C occur with FARXIGA see Adverse Reactions (6.1). Monitor LDL-C and treat per standard of care after initiating FARXIGA.本药可使 L
16、DL-C 升高，开始用药后应监测 LDL-C 并进行标准治疗。5.6 Bladder Cancer 膀胱癌Across 22 clinical studies, newly diagnosed cases of bladder cancer were reported in 10/6045 patients (0.17%) treated with FARXIGA and 1/3512 patient (0.03%) treated with placebo/comparator. After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there w
