Package InsertMenomuneACYW135.docx
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Package InsertMenomuneACYW135.docx
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PackageInsertMenomuneACYW135
PackageInsert-Menomune-A/C/Y/W-135
HIGHLIGHTSOFPRESCRIBINGINFORMATION
ThesehighlightsdonotincludealltheinformationneededtouseMenomune®–A/C/Y/W-135vaccinesafelyandeffectively.SeefullprescribinginformationforMenomune®–A/C/Y/W-135vaccine.
Menomune®–A/C/Y/W-135,MeningococcalPolysaccharideVaccine,GroupsA,C,YandW-135Combined
Suspensionforsubcutaneousinjection
InitialU.S.Approval:
1981
----------------------------RECENTMAJORCHANGES---------------
Contraindications(4)[1/2009]
WarningsandPrecautions(5)[1/2009]
DeferralofvaccinationduringacuteillnessmovedfromContraindicationstoWarningsandPrecautions.
----------------------------INDICATIONSANDUSAGE---------------
∙Menomune–A/C/Y/W-135vaccineisavaccineindicatedforactiveimmunizationagainstinvasivemeningococcaldiseasecausedbyNeisseriameningiditisserogroupsA,C,Y,andW-135.Menomune–A/C/Y/W-135vaccineisapprovedforuseinpersons2yearsofageandolder.
(1)
----------------------DOSAGEANDADMINISTRATION------------
∙Single0.5mLsubcutaneousinjection.
(2)
---------------------DOSAGEFORMSANDSTRENGTHS---------
∙Menomune–A/C/Y/W-135vaccineissuppliedasasingledoseormultidose(10dose)vialoflyophilizedvaccine,withcorrespondingsingledoseormultidosevialofdiluent.Afterreconstitutionofthelyophilizedvaccinewiththediluent,eachdoseconsistsofa0.5mLsuspensionforinjection.(3)
-------------------------------CONTRAINDICATIONS------------
∙Donotadministertoanyonewithahistoryofasevereallergicreaction(eg,anaphylaxis)toMenomune–A/C/Y/W-135vaccineoranycomponentofthevaccine.(4)
-----------------------WARNINGSANDPRECAUTIONS-------------------
∙Thestopperstothevialsoflyophilizedvaccineanddiluentcontaindrynaturallatexrubberthatmaycauseallergicreactions.(5.1)
------------------------------ADVERSEREACTIONS--------------
∙Common(>10%)adverseeventsinchildren2to10yearsofagewereinjectionsitepain,drowsiness,irritability,anddiarrhea.(6)
∙Common(>10%)adverseeventsinpersons11to55yearsofagewerepain,redness,andindurationattheinjectionsite,headache,fatigue,malaise,arthralgia,anddiarrhea.(6)
ToreportSUSPECTEDADVERSEREACTIONS,contactSanofiPasteurInc.at1-800-822-2463(1-800-VACCINE)orVAERSat1-800-822-7967orhttp:
//vaers.hhs.gov.
------------------------------DRUGINTERACTIONS--------------
∙DonotmixMenomune–A/C/Y/W-135vaccinewithothervaccinesinthesamesyringeorvial.(7)
∙ImmunosuppressivetherapiesmayreducetheimmuneresponsetoMenomune–A/C/Y/W-135vaccine.(7)
∙NosafetyandimmunogenicitydataareavailableontheconcomitantadministrationofMenomune–A/C/Y/W-135vaccinewithotherUSlicensedvaccines.(7)
-----------------------USEINSPECIFICPOPULATIONS-------
∙Pregnancy:
Nohumanoranimaldata.Useonlyifclearlyneeded.(8.1)
∙Geriatrics:
Notknownwhetherpersonsaged65yearsandolderresponddifferentlyfromyoungerpersons.(8.4)
See17forPatientCounselingInformation.
Revised:
[January2009]
______________________________________________________________________________________________________________________________________
FULLPRESCRIBINGINFORMATION:
CONTENTS*
1.INDICATIONSANDUSAGE
2.DOSAGEANDADMINISTRATION
2.1Administration
2.2PrimaryImmunization
2.3Revaccination
3.DOSAGEFORMSANDSTRENGTHS
4.CONTRAINDICATIONS
4.1Hypersensitivity
5.WARNINGSANDPRECAUTIONS
5.1Latex
5.2ManagementofAcuteAllergicReactions
5.3ModerateorSevereAcuteIllness
5.4LimitationsofVaccineEffectivness
5.5AlteredImmunocompetence
6.ADVERSEREACTIONS
6.1DatafromClinicalStudies
6.2DatafromPost-MarketingExperience
7.DRUGINTERACTIONS
8.USEINSPECIFICPOPULATIONS
8.1Pregnancy
8.2NursingMothers
8.3PediatricUse
8.4GeriatricUse
9.DESCRIPTION
10.CLINICALPHARMACOLOGY
12.1MechanismofAction
11.NON-CLINICALTOXICOLOGY
13.1Carcinogenesis,mutagenesis,impairmentoffertility
12.CLINICALSTUDIES
13.REFERENCES
14.HOWSUPPLIEDSTORAGEANDHANDLING
16.1HowSupplied
16.2Storage
15.PATIENTCOUNSELINGINFORMATION
*Sectionsorsubsectionsomittedfromthefullprescribinginformationarenotlisted.
FULLPRESCRIBINGINFORMATION:
1.INDICATIONSANDUSAGE
Menomune®–A/C/Y/W-135,MeningococcalPolysaccharideVaccine,GroupsA,C,YandW-135Combined,isindicatedforactiveimmunizationforthepreventionofinvasivemeningococcaldiseasecausedbyNeisseriameningitidisserogroupsA,C,Y,andW-135.Menomune–A/C/Y/W-135vaccineisapprovedforuseinpersons2yearsofageandolder.
Menomune–A/C/Y/W-135vaccineisnotindicatedforthepreventionofmeningitiscausedbymicroorganismsotherthanN.meningitidisserogroupsA,C,Y,andW-135.Menomune–A/C/Y/W-135vaccineisnotindicatedfortreatmentofmeningococcalinfections.
2.DOSAGEANDADMINISTRATION
2.1.Administration
Thelyophilizedvaccineshouldbeawhiteoroff-whitecolortoalightbeigecolor.Thediluentusedforreconstitutionisaclearliquid.
Usingasuitablesizesyringe,withdrawthesupplieddiluent(0.6mLforsingle-dosepresentationand6.0mLformultidosepresentation)andinjectintothevialcontainingthelyophilizedvaccine.Swirlthevialuntilthevaccineisthoroughlydissolved.Whenreconstituted,thevaccineshouldbeaclear,colorlessliquid.
Parenteraldrugproductsshouldbeinspectedvisuallyforparticulatematteranddiscolorationpriortoadministration,wheneversolutionandcontainerpermit.Ifeitheroftheseconditionsexist,thevaccineshouldnotbeadministered.
Withdrawandadministera0.5mLdoseofMenomune–A/C/Y/W-135vaccinebysubcutaneousinjection.
Vaccinesuppliedinsingledosevialsshouldbeusedimmediatelyafterreconstitution.
Vaccinesuppliedinmultidosevialsmaybeusedforupto35daysafterreconstitutionifstoredat2°to8°C(35°to46°F).[SeeHowSupplied/StorageandHandling(16.2).]
2.2.PrimaryImmunization
PrimaryimmunizationwithMenomune–A/C/Y/W-135vaccineconsistsofasingle0.5mLdoseadministeredsubcutaneously.Thepreferredsiteofadministrationisthedeltoidregion.
TheACIP(AdvisoryCommitteeonImmunizationPractices)hasspecficrecommendationsforuseofmeningococcalvaccines.
(1)
(2)(3)
2.3.Revaccination
TheACIPhasrecommendationsforrevaccinationagainstmeningococcaldiseaseforpersonsathighriskwhowerepreviouslyvaccinatedwithMenomune–A/C/Y/W-135vaccine.
(1)(3)If
Menomune–A/C/Y/W-135vaccineisusedforrevaccination,thedoseis0.5mLadministeredsubcutaneously.
3.DOSAGEFORMSANDSTRENGTHS
Menomune–A/C/Y/W-135vaccineissuppliedasalyophilizedvaccine,inasingledoseoramultidose(10dose)vial,withcorrespondingsingledoseormultidosevialofdiluent.Thelyophilizedvaccineisreconstitutedwiththediluent[seeDosageandAdministration(2.1)].Afterreconstitution,eachdoseconsistsofa0.5mLsuspensionforinjection.SeeDescription(11)forthecompletelistingofingredients.
4.CONTRAINDICATIONS
4.1.Hypersensitivity
Donotadministertoanyonewithahistoryofasevereallergicreaction(e.g.,anaphylaxis)toMenomune–A/C/Y/W-135vaccineoranycomponentofthevaccine[seeDescription(11)].
5.WARNINGSANDPRECAUTIONS
5.1.Latex
Thestopperstothevialsoflyophilizedvaccineanddiluentcontaindrynaturallatexrubberthatmaycauseallergicreactionsinlatexsensitivepersons.
5.2.ManagementofAcuteAllergicReactions
Appropriatemedicaltreatmentmustbeavailabletomanagepossibleanaphylacticreactionsfollowingadministrationofthevaccine.
5.3.ModerateorSevereAcuteIllness
Toavoiddiagnosticconfusionbetweenmanifestationsofanacuteillnessandpossiblevaccineadverseeffects,vaccinationwithMenomune–A/C/Y/W-135vaccineshouldbepostponedinpersonswithmoderateorsevereacuteillness.(4)
5.4.LimitationsofVaccineEffectivness
Menomune–A/C/Y/W-135vaccinemaynotprotectallrecipients.
5.5.AlteredImmunocompetence
Personswhoareimmunosuppressed,includingpersonsreceivingimmunosuppressivetherapy,mayhaveadiminishedimmuneresponsetoMenomune–A/C/Y/W-135vaccine[seeDrugInteractions(7)].
6.ADVERSEREACTIONS
6.1.DatafromClinicalStudies
Becauseclinicaltrialsareconductedunderwidelyvaryingconditions,adversereactionratesobservedintheclinicaltrialsofavaccinecannotbedirectlycomparedtoratesintheclinicaltrialsofanothervaccineandmaynotreflecttheratesobservedinclinicalpractice.
Inthreeclinicaltrialsprimarilydesignedtoassessthesafetyandimmunogenicityofanothervaccine,Menactra®[Meningococcal(GroupsA,C,Y,W-135)PolysaccharideDiphtheriaToxoidConjugateVaccine],participantswererandomizedtoreceiveMenactraorMenomune–A/C/Y/W-135vaccine,whichwasusedasacontrolvaccine.Inthesethreetrials,1519children2-10yearsofage,972persons11-18yearsofage,and1170adults18-55yearsofage,respectively,receivedadoseofMenomune–A/C/Y/W-135vaccine.Overall,ofthechildren2-10yearsofagewhoreceivedMenactraorMenomune–A/C/Y/W-135vaccine,68%wereenrolledatUSsitesand32%wereenrolledataChileansite.ThemedianagesofUSandChileanchildrenwere6and5years,respectively;50.5%weremales;and92.0%wereCaucasian.Amongparticipants11-55yearsofagewhoreceivedMenactraorMenomune–A/C/Y/W-135vaccine,allwereenrolledatUSsites;54.8%werefemale;87.7%wereCaucasian.
Solicitedlocalandsystemicreactionsweremonitoreddailyfor7dayspost-vaccinationusingadiarycard.Informationonseriousadverseeventswascollectedatinterimclinicvisitsandbytelephonei
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