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1、FortheuseofaRegisteredMedicalPractitioneroraHospitaloraLaboratoryonly仅供注册医生、医院、实验室使用Lamivudine,ZidovudineandNevirapineTabletsIP拉米夫定,齐多夫定和奈韦拉平片(印度药典级)Duovir-N(商品名)Warning警告Duovir-Nisnotintendedforuseinpatientswhoarejustinitiatingtherapywithnevirapine.Duovir-Nshou
2、ldbeadministeredonlytopatientswhohavereceivedZidovudine+Lamivudine(standarddoses)+Nevirapine(200mgOD)for2weeksandhavedemonstratedadequatetolerabilitytoNevirapine(seeIndications,DosageandAdministration).Duovir-N不适合那些刚开始使用奈韦拉平治疗的患者,Duovir-N只应施用于那些已经接受齐多夫定+拉米夫定(标准剂
3、量)+奈韦拉平(200毫克,每天一次)达2周,并证明对奈韦拉平具有足够耐受性的患者(见适应症、剂量和服用)。ZidovudinehasbeenassociatedwithhaematologictoxicityincludingNeutropeniaandsevereanaemia.Particularlyinpatientswithadvanceddisease(seeWarningsandPrecautions).ProlongeduseofZidovudinehasbeenassociatedwithsympto
4、maticmyopathy.齐多夫定与血液学毒性相关,包括中性粒细胞减少和严重贫血,特别是长期使用齐多夫定,一直伴随症状肌病的晚期患者(见警告和注意事项)。Severe,life-threateningskinreactions,includingfatalcases,haveoccurredinpatientstreatedwithNevirapine.ThesehaveincludedcasesofStevens-Johnsonsyndrome.Toxicepidermalnecrolysis,andhyperse
5、nsitivityreactionscharacterisedbyrash,constitutionalfindingsandorgandysfunction.PatientsdevelopingsignsorsymptomsofsevereskinreactionsorhypersensitivityreactionsmustdiscontinueNevirapineassoonaspossible(seeWarningsandPrecautions).使用奈韦拉平治疗的患者,已经发生过严重、危及生命的皮肤反应,包括
6、致命的病例,包括史蒂文斯-约翰逊综合征(即:重症多形性红斑)病例、中毒性表皮坏死、和过敏性反应,特征是皮疹、原发性症兆和器官功能障碍,出现严重的皮肤反应、或过敏反应症状或体征的患者,必须尽快停止使用奈韦拉平(见警告和注意事项)。Severe,life-threatening,andinsomecasesfatalhepatotoxicity,includingfulminantandcholestatichepatitis,hepaticnecrosisandhepaticfailurehasbeenreportedi
7、npatientstreatedwithNevirapine.Insomecases,patientspresentedwithnon-specificprodromalsignsorsymptomsofhepatitisandprogressedtohepaticfailure.Theseeventsareoftenassociatedwithrash.WomenandpatientswithhigherCD4counts,areatincreasedriskofthesehepaticevents.Womenwit
8、hCD4counts>250cells/mm3,includingpregnantwomenreceivingchronictreatmentforHIVinfection,areatconsiderablyhigherriskoftheseevents.Patientswithsignsorsymptomsofhepatitis