左乙拉西坦注射液EMEA说明书

《左乙拉西坦注射液EMEA说明书》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、ANNEXISUMMARYOFPRODUCTCHARACTERISTICS11.NAMEOFTHEMEDICINALPRODUCTLevetiracetamSUN100mg/mlconcentrateforsolutionforinfusion2.QUALITATIVEANDQUANTITATIVECOMPOSITIONEachmlcontains100mgoflevetiracetam.Each5mlvialcontains500mgoflevetiracetam.Excipients:Eachvialcont

2、ains57mgofsodium(11.4mg/ml).Forafulllistofexcipients,seesection6.1.3.PHARMACEUTICALFORMConcentrateforsolutionforinfusion(sterileconcentrate).Clear,colourlessconcentrate.4.CLINICALPARTICULARS4.1TherapeuticindicationsLevetiracetamSUNisindicatedasmonotherapyinth

3、etreatmentofpartialonsetseizureswithorwithoutsecondarygeneralisationinpatientsfrom16yearsofagewithnewlydiagnosedepilepsy.LevetiracetamSUNisindicatedasadjunctivetherapy-inthetreatmentofpartialonsetseizureswithorwithoutsecondarygeneralisationinadultsandchildren

4、from4yearsofagewithepilepsy-inthetreatmentofmyoclonicseizuresinadultsandadolescentsfrom12yearsofagewithJuvenileMyoclonicEpilepsy-inthetreatmentofprimarygeneralisedtonic-clonicseizuresinadultsandadolescentsfrom12yearsofagewithIdiopathicGeneralisedEpilepsy.Leve

5、tiracetamSUNconcentrateisanalternativeforpatientswhenoraladministrationistemporarilynotfeasible.4.2PosologyandmethodofadministrationPosologyMonotherapyforadultsandadolescentsfrom16yearsofageTherecommendedstartingdoseis250mgtwicedailywhichshouldbeincreasedtoan

6、initialtherapeuticdoseof500mgtwicedailyaftertwoweeks.Thedosecanbefurtherincreasedby250mgtwicedailyeverytwoweeksdependingupontheclinicalresponse.Themaximumdoseis1500mgtwicedaily.Add-ontherapyforadults(≥18years)andadolescents(12to17years)weighing50kgormoreThein

7、itialtherapeuticdoseis500mgtwicedaily.Thisdosecanbestartedonthefirstdayoftreatment.2Dependingupontheclinicalresponseandtolerability,thedailydosecanbeincreasedupto1,500mgtwicedaily.Dosechangescanbemadein500mgtwicedailyincreasesordecreaseseverytwotofourweeks.Du

8、rationoftreatmentThereisnoexperiencewithadministrationofintravenouslevetiracetamforlongerperiodthan4days.SpecialpopulationsElderly(65yearsandolder)Adjustmentofthedoseisrecommendedinelderl