FLUAD, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Main information

  • Trade name:
  • FLUAD, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
  • Dosage:
  • 0.5
  • Pharmaceutical form:
  • Suspension for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLUAD, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0919/002/001
  • Authorization date:
  • 18-08-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FLUAD,suspensionforinjectioninpre-filledsyringe

InfluenzaVaccine,SurfaceAntigen,Inactivated,AdjuvantedwithMF59C.1

(2011/2012SEASON)

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Influenzavirussurfaceantigens(haemagglutininandneuraminidase)*,ofstrains:

A/California/07/2009(H1N1)-derivedstrainusedNYMCX-18115microgramsHA**

A/Perth/16/2009(H3N2)-likestrainusedNYMCX-187derivedfrom

A/Victoria/210/2009 15microgramsHA**

B/Brisbane/60/2008-derivedstrainusedNYMCBX-35 15microgramsHA**

*propagatedineggsandadjuvantedwithMF59C.1

**haemagglutinin

Adjuvant:MF59C.1whichisanexclusiveadjuvant(PatentEP0399843B1):9.75mgsqualene,1.175mgpolysorbate

80,1.175mgsorbitantrioleate,0.66mgsodiumcitrate,0.04mgcitricacid,waterforinjections.

Foronedoseof0.5ml

ThisvaccinecomplieswiththeWHOrecommendations(NorthernHemisphere)andEUdecisionforthe2011/2012

season.

Forafulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

Suspensionforinjectioninpre-filledsyringe.

Thevaccineappearsasamilky-whitesuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Activeimmunisationagainstinfluenzaintheelderly(65yearsofageandover),especiallyforthosewithanincreased

riskofassociatedcomplications(i.e.patientsaffectedbyunderlyingchronicdiseasesincludingdiabetes,cardiovascular

andrespiratorydiseases).

TheuseofFLUADshouldbebasedonofficialrecommendations.

4.2Posologyandmethodofadministration

Asingle0.5mldoseshouldbeadministeredbyintramuscularinjectionintothedeltoidmuscle.Duetothepresenceof

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Forinstructionsforpreparation,seesection6.6.

4.3Contraindications

Hypersensitivitytotheactivesubstances,toanyoftheexcipientsandtoeggs,chickenproteins,e.g.suchas

ovoalbumin,kanamycinandneomycinsulphate,formaldehydeandcetyltrimethylammoniumbromide(CTAB).

Immunisationshallbepostponedinpatientswithfebrileillnessoracuteinfection.

4.4Specialwarningsandprecautionsforuse

Aswithallinjectablevaccines,appropriatemedicaltreatmentandsupervisionshouldalwaysbereadilyavailablein

caseofananaphylacticeventfollowingtheadministrationofthevaccine.

FLUADshouldundernocircumstancesbeadministeredintravascularlyorsubcutaneously.

Antibodyresponseinpatientswithendogenousoriatrogenicimmunosuppressionmaybeinsufficient.

Aprotectiveresponsemaynotbeelicitedinallvaccinees.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

FLUADmaybegivenatthesametimeasothervaccines.Immunisationshouldbecarriedoutonseparatelimbs.It

shouldbenotedthattheadversereactionsmaybeintensified.

Theimmunologicalresponsemaybediminishedifthepatientisundergoingimmunosuppressanttreatment.

Followinginfluenzavaccination,falsepositiveresultsinserologytestsusingtheELISAmethodtodetectantibodies

againstHIV1,hepatitisCandespeciallyHTLV1havebeenobserved.TheWesternBlottechniquedisprovesthefalse-

positiveELISAresults.ThetransientfalsepositivereactionscouldbeduetotheIgMresponsebythevaccine.

4.6Fertility,pregnancyandlactation

Notapplicable.

4.7Effectsonabilitytodriveandusemachines

Thevaccinehasnoornegligibleinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

Ahigherincidenceofmildpost-immunisationreactionshasbeenreportedwithFluadcomparedtonon-adjuvanted

influenzavaccines.

Adversereactionsobservedfromclinicaltrials

ThesafetyofFluadisassessedinopenlabel,uncontrolledclinicaltrialsperformedasanannualupdaterequirement,

includingatleast50elderlyaged65yearsorolder.Safetyevaluationisperformedduringthefirst3daysfollowing

vaccination.

Thefollowingundesirableeffectshavebeenobservedduringclinicaltrialswiththefollowingfrequencies:

Verycommon(1/10);common(1/100,<1/10);uncommon(1/1,000,<1/100);rare(1/10,000,<1/1,000);veryrare

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Nervoussystemdisorders

Common(1/100,<1/10):Headache*

Skinandsubcutaneoustissuedisorders

Common(1/100,<1/10):Sweating*

Musculoskeletalandconnectivetissuedisorders

Common(1/100,<1/10):Myalgia,arthralgia*

Generaldisordersandadministrationsiteconditions

Common(1/100,<1/10):Fever,malaise,shivering,fatigue.

Localreactions:redness,swelling,painatinjectionsite,ecchymosis,induration.*

*Thesereactionsusuallydisappearwithin1-2dayswithouttreatment.

Adversereactionsreportedfrompost-marketingsurveillance

Adversereactionsreportedfrompostmarketingsurveillanceare,nexttothereactionswhichhavealsobeenobserved

duringtheclinicaltrials,thefollowing:

Bloodandlymphaticsystemdisorders

Transientthrombocytopenia,transientlymphadenopathy

Immunesystemdisorders

Allergicreactions,inrarecasesleadingtoshock,havebeenreported.

Nervoussystemdisorders

Neuralgia,paraesthesia,convulsions

Neurologicaldisorderssuchasencephalomyelitis,neuritisandGuillainBarrèsyndrome.

Vasculardisorders

Vasculitiswithtransientrenalinvolvementandexudativeerythemamultiforme.

Skinandsubcutaneoustissuedisorders

Generalisedskinreactionsincludingpruritus,urticariaornon-specificrash.

Musculoskeletalandconnectivetissuedisorders

painintheextremity,muscularweakness

Generaldisordersandadministrationsiteconditions

Asthenia,Influenza-LikeIllness(ILI)

4.9Overdose

Overdosageisunlikelytohaveanyuntowardeffect.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Influenzavaccine,ATCcode:J07BB02.

Seroprotectionisgenerallyobtainedwithin2to3weeks.Thedurationofpostvaccinationimmunitytohomologous

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Althoughcomparativefieldefficacytrialshavenotbeenperformed,theantibodyresponsetoFLUADisincreased

whencomparedtotheresponsetovaccineswithoutadjuvant,andismostpronouncedforBandA/H3N2influenza

antigens.

Thisincreasedresponseisseenparticularlyinelderlysubjectswithlowpre-immunisationtitreand/orwithunderlying

diseases(diabetesandcardiovascularandrespiratorydiseases)whoareatincreasedriskofcomplicationsofinfluenza

infection.AsimilarimmunogenicityprofilehasbeennotedafterasecondandthirdimmunisationwithFLUAD.

SignificantantibodyrisesafterimmunisationwithFLUADhavealsobeenshownagainstheterovariantstrains,

antigenicallydifferentfromthoseincludedinthevaccine.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Non-clinicaldatarevealnospecialhazardforhumansbasedonconventionalstudiesofrepeated-dosetoxicity,

genotoxicityandlocaltolerance.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Adjuvant:seesection2.

Other:

Sodiumchloride

Potassiumchloride

Potassiumdihydrogenphosphate

Disodiumphosphatedihydrate

Magnesiumchloridehexahydrate

Calciumchloridedihydrate

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3Shelflife

1year.

6.4Specialprecautionsforstorage

Storeinarefrigerator(2°C-8°C).Donotfreeze.Keepthesyringeintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

0.5mlofsuspensionforinjectioninpre-filledsyringe(typeIglass)presentedwithorwithoutneedle.

Packof1,withorwithoutneedle.

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Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Thevaccineshouldbeallowedtoreachroomtemperaturebeforeuse.Gentlyshakebeforeuse.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisVaccinesandDiagnosticsS.r.l

ViaFiorentina1

53100Siena

Italy

8MARKETINGAUTHORISATIONNUMBER

PA919/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18August2000

Dateoflastrenewal:08June2005

10DATEOFREVISIONOFTHETEXT

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