尼可地尔注射液药品说明书(英文)

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1、ChugaiPharmaceuticalCo.,Ltd.1Revised:March2010(10thversion)StandardCommodityClassificationNo.ofJapan872171-DRUGFORTREATMENTOFUNSTABLEANGINAPECTORISANDACUTEHEARTFAILURE-®SIGMARTInjection2mg®SIGMARTInjection12mg®SIGMARTInjection48mgNote1)prescriptiondrugStorageBrandnameSIGMARTInjection

2、Storeattemperatures10°Corbelow.2mg12mg48mgApprovalNo.20500AMZ0020500AMZ0020800AMZ10348349235ShelfLifeIndicatedonthelabelandthepackageDateoflistingintheNHIAug1993Aug1993June1997(twoyearsfromthedateofreimbursementpriceproduction).DateofinitialmarketinginJapanSept1993Sept1993June1997Dateoflatestree

3、xaminationAug2002Aug2002Aug2002(Unstableanginapectoris)AdditionalindicationOct2007Oct2007Oct2007Note1)Caution-Useonlypursuanttotheprescriptionofaphysician,etc.CONTRAINDICATIONS(SIGMARTInjectionishydrochloridehydrate,ortadalafil).(See“3.Drugcontraindicatedinthefollowingpatients.)Interactions.”)1.

4、Patientswithseverehepaticorrenaldysfunction.(SinceDESCRIPTIONmetabolicandexcretoryfunctionsareimpaired,theBrandnameSIGMARTInjectionbloodconcentrationofSIGMARTmaybecomehigh).2mg12mg48mg2.Patientswithseverecerebraldysfunction.(SIGMARTIngredient/NicorandilNicorandilNicorandilmaynegativelyaffectcere

5、bralfunctionwhenbloodcontent(content2mg,JP12mg,JP48mg,JPpressureisloweredexcessively.)pervial)3.Patientswithseverehypotensionorcardiogenicshock.InactiveD-mannitol,D-mannitol,D-mannitol,(SinceSIGMARTlowersbloodpressure,theseingredient3mg18mg72mgsymptomsmaybeexacerbated.)(contentperSodiumcitratehy

6、drate4.PatientswithEisenmenger'ssyndromeorprimaryvial)pulmonaryhypertension.(SinceSIGMARTreducesDosageformColorless,transparentvial(lyophilizedvenousreturn,itmayintensifyreducedbloodpressureinjection)andreducedcardiacoutput.)Color,Whitemassorpowder5.Patientswithrightventricularinfarction.(Sinced

7、escriptionSIGMARTreducesvenousreturn,itmayinducecardiogenicshock.)pHandosmoticpressureratiofollowingreconstitution6.Patientshavingsymptomsofdehydration.(SinceDiluentIsotonicsodium5%glucosesolutionSIGMARTreducesvenousreturnan