cervarix 包装插页

《cervarix 包装插页》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、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