盐酸苯达莫司汀(美)

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1、HIGHLIGHTSOFPRESCRIBINGINFORMATION-------------------------WARNINGSANDPRECAUTIONS---------------------Thesehighlightsdonotincludealltheinformationneededtouse•Myelosuppression:Maywarranttreatmentdelayordosereduction.TREANDAsafelyandeffectively.SeefullprescribinginformationforMonitorclosely

2、andrestarttreatmentbasedonANCandplateletcountTREANDA.recovery.Complicationsofmyelosuppressionmayleadtodeath.(5.1)•Infections:Monitorforfeverandothersignsofinfectionandtreat®TREANDA(bendamustinehydrochloride)forInjection,forintravenouspromptly.(5.2)infusion•InfusionReactionsandAnaphylaxis:

3、SevereanaphylacticreactionshaveInitialU.S.Approval:2008occurred.Monitorclinicallyanddiscontinuedrugforseverereactions.Ask----------------------------RECENTMAJORCHANGES-------------------------patientsaboutreactionsafterthefirstcycle.Considerpre-treatmentforWarningsandPrecautions,Extravasa

4、tion(5.7)01/2010cyclessubsequenttomilderreactions.(5.3)•TumorLysisSyndrome:Mayleadtoacuterenalfailureanddeath.Take----------------------------INDICATIONSANDUSAGE---------------------------precautionsinpatientsathighrisk.(5.4)TREANDAforInjectionisanalkylatingdrugindicatedfortreatmentof•Ski

5、nReactions:Discontinueforsevereskinreactions.CasesofSJSandpatientswith:TEN,somefatal,havebeenreportedwhenTREANDAwasadministered•Chroniclymphocyticleukemia(CLL).Efficacyrelativetofirstlineconcomitantlywithallopurinolandothermedicationsknowntocausethesetherapiesotherthanchlorambucilhasnotbe

6、enestablished.(1.1)syndromes.(5.5)•IndolentB-cellnon-Hodgkin’slymphoma(NHL)thathasprogressed•OtherMalignancies:Pre-malignantandmalignantdiseaseshavebeenduringorwithinsixmonthsoftreatmentwithrituximaborarituximabreported.(5.6)containingregimen.(1.2)•Extravasation:Takeprecautionstoavoidextr

7、avasation,including----------------------DOSAGEANDADMINISTRATION------------------------monitoringintravenousinfusionsiteduringandafteradministration.(5.7)ForCLL:•UseinPregnancy:Fetalharmcanoccurwhenadministeredtoapregnant2•100mg/minfusedintravenouslyover30minuteson