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

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1、FULLPRESCRIBINGINFORMATION1INDICATIONSANDUSAGE适应症和用途FARXIGA(dapagliflozin)isindicatedasanadjuncttodietandexercisetoimproveglycemiccontrolinadultswithtype2diabetesmellitus[seeClinicalStudies(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。1.1LimitationofUse使用限制FARXIGAisnotrecommendedforpatientswithtype1di

2、abetesmellitusorforthetreatmentofdiabeticketoacidosis.本药不适用于1型糖尿病或糖尿病酮症酸中毒患者。2DOSAGEANDADMINISTRATION用法用量2.1RecommendedDosing推荐剂量TherecommendedstartingdoseofFARXIGAis5mgoncedaily,takeninthemorning,withorwithoutfood.InpatientstoleratingFARXIGA5mgoncedailywhorequireadditionalglycemiccontrol,

3、thedosecanbeincreasedto10mgoncedaily.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。Inpatientswithvolumedepletion,correctingthisconditionpriortoinitiationofFARXIGAisrecommended[seeWarningsandPrecautions(5.1),UseinSpecificPopulations(8.5,8.6),andPatientCounseling

4、Information(17)].血容量减少患者，推荐用药前应先纠正血容量减少。2.2PatientswithRenalImpairment肾功能不全时剂量AssessmentofrenalfunctionisrecommendedpriortoinitiationofFARXIGAtherapyandperiodicallythereafter.建议在开始使用本药前及使用期间定期评估肾功能。2FARXIGAshouldnotbeinitiatedinpatientswithaneGFRlessthan60mL/min/1.73m.2肾小球滤过率＜60ml/(min/1.7

5、3m)患者不得开始用药。2Nodoseadjustmentisneededinpatientswithmildrenalimpairment(eGFRof60mL/min/1.73morgreater).2轻度肾功能损害者[肾小球滤过率≥60ml/(min/1.73m)]无需调整剂量。2FARXIGAshouldbediscontinuedwheneGFRispersistentlylessthan60mL/min/1.73m[seeWarningsandPrecautions(5.2)andUseinSpecificPopulations(8.6)].2肾小球滤过率持续＜

6、60ml/(min/1.73m)时应停药。3DOSAGEFORMSANDSTRENGTHS剂型和规格FARXIGA5mgtabletsareyellow,biconvex,round,film-coatedtabletswith“5”engravedononesideand“1427”engravedontheotherside.FARXIGA10mgtabletsareyellow,biconvex,diamond-shaped,film-coatedtabletswith“10”engravedononesideand“1428”engravedontheother

7、side.达格列净片(1)5mg。(2)10mg。4CONTRAINDICATIONS禁忌症HistoryofaserioushypersensitivityreactiontoFARXIGA[seeAdverseReactions(6.1)].Severerenalimpairment,end-stagerenaldisease(ESRD),orpatientsondialysis[seeUseinSpecificPopulations(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。