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1、HIGHLIGHTSOFPRESCRIBINGINFORMATION-----------------------WARNINGSANDPRECAUTIONS----------------Thesehighlightsdonotincludealltheinformationneededtouse?Becausevaccineesmaydevelopsyncope,sometimesresultinginfallingCERVARIXsafelyandeffectively.Seefullprescribinginformationforwithinjury,observationfor15
2、minutesafteradministrationisCERVARIX.recommended.Syncope,sometimesassociatedwithtonic-clonicmovementsandotherseizure-likeactivity,hasbeenreportedfollowingCERVARIX[HumanPapillomavirusBivalent(Types16and18)Vaccine,vaccinationwithCERVARIX.Whensyncopeisassociatedwithtonic-Recombinant]clonicmovements,the
3、activityisusuallytransientandtypicallySuspensionforIntramuscularInjectionrespondstorestoringcerebralperfusionbymaintainingasupineorInitialU.S.Approval:2009Trendelenburgposition.(5.1)----------------------------INDICATIONSANDUSAGE---------------------?Thetipcapsoftheprefilledsyringesmaycontainnatural
4、rubberlatexCERVARIXisavaccineindicatedforthepreventionofthefollowingwhichmaycauseallergicreactionsinlatex-sensitiveindividuals.(5.2)diseasescausedbyoncogenichumanpapillomavirus(HPV)types16and18:------------------------------ADVERSEREACTIONS-----------------------?cervicalcancer,?Mostcommonlocaladver
5、sereactionsin≥20%ofsubjectswerepain,?cervicalintraepithelialneoplasia(CIN)grade2orworseandredness,andswellingattheinjectionsite.(6.1)adenocarcinomainsitu,and?Mostcommongeneraladverseeventsin≥20%ofsubjectswerefatigue,?cervicalintraepithelialneoplasia(CIN)grade1.(1.1)headache,myalgia,gastrointestinals
6、ymptoms,andarthralgia.(6.1)CERVARIXisapprovedforuseinfemales9through25yearsofage.LimitationsofUseandEffectiveness(1.2)ToreportSUSPECTEDADVERSEREACTIONS,contact?CERVARIXdoesnotprovideprotectionagainstdiseaseduetoallHPVGlaxoSmithKlineat1-888-825-5249orVAERSat1-800-822-7967ortypes.(14.3)www.vaers.hhs.g
7、ov.?CERVARIXhasnotbeendemonstratedtoprovideprotectionagainst----------------------------------DRUGINTERACTIONS----------------------------diseasefromvaccineandnon-vaccineHPVtypestowhichawomanhasDonotm
