ADDIFLU SUSPENSION FOR INJECTION

Main information

  • Trade name:
  • ADDIFLU SUSPENSION FOR INJECTION
  • Dosage:
  • 250 %v/ v
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADDIFLU SUSPENSION FOR INJECTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0973/001/001
  • Authorization date:
  • 01-09-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0973/001/001

CaseNo:2067720

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

SanofiPasteurMSDS.p.A.

ViadegliAldobrandeschi,15,1-00163Roma,Italy

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ADDIFLUSuspensionforInjectioninpre-filledsyringe.InfluenzaVaccine,SurfaceAntigen,Inactivated,AdjuvantedwithMF59C.1

(2009/2010Season)

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom20/08/2009until07/06/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/08/2009 CRN 2067720 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ADDIFLUSuspensionforInjectioninpre-filledsyringeInfluenzaVaccine,SurfaceAntigen,Inactivated,Adjuvanted

withMF59C.1

(2009/2010Season).

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Influenzavirussurfaceantigens(haemaggultininandneuraminidase)*,ofstrains

A/Brisbane/59/2007(H1N1)-likestrain

(A/Brisbane/59/2007,IVR-148) 15micrograms**

A/Brisbane/10/2007(H3N2)-likestrain

(A/Uruguay/716/2007,NYMCX–175C) 15micrograms**

B/Brisbane/60/2008–likestrain(B/Brisbane/60/2008) 15micrograms**

*propagatedineggsandadjuvantedwithMF59C.1

**haemagglutinin

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

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

Foronedoseof0.5ml

ThisvaccinecomplieswiththeWHOrecommendations(NorthernHemisphere)andEUdecisionforthe2009/2010

season.

Forexcipientsseesection6.1

3PHARMACEUTICALFORM

Suspensionforinjectioninpre-filledsyringe.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Activeimmunisationagainstinfluenzaintheelderly(65yearsofageandover),especiallyforthosewithanincreased

riskofassociatedcomplications(i.e.patientsaffectedbyunderlyingchronicdiseasesincludingdiabetes,cardiovascular

andrespiratorydiseases).

4.2Posologyandmethodofadministration

Asingle0.5mldoseshouldbeadministeredbyintramuscularinjectionintothedeltoidmuscle.Duetothepresenceof

Irish Medicines Board

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4.3Contraindications

Hypersensitivitytotheactivesubstances,toanyoftheexcipientsandtoeggs,chickenproteins,kanamycinand

neomycinsulphate,formaldehydeandcetyltrimethylammoniumbromide(CTAB).

Immunisationshallbepostponedinpatientswithfebrileillnessoracuteinfection.

4.4Specialwarningsandprecautionsforuse

Aswithallinjectablevaccines,appropriatemedicaltreatmentandsupervisionshouldalwaysbereadilyavailablein

casearareanaphylacticeventoccursfollowingtheadministrationofthevaccine.

ThevaccineAddiflushouldundernocircumstancesbeadministeredintravascularlyorsubcutaneously.

Antibodyresponseinpatientswithendogenousoriatrogenicimmunosuppressionmaybeinsufficient.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thevaccinemaybegivenatthesametimeasothervaccines.Immunisationshouldbecarriedoutonseparatelimbs.It

shouldbenotedthattheadversereactionsmaybeintensified.

Theimmunologicalresponsemaybediminishedifthepatientisundergoingimmunosuppressanttreatment.

Followinginfluenzavaccination,falsepositiveresultsinserologytestsusingtheELISAmethodtodetectantibodies

againstHIV1,hepatitisCand,especiallyHTLV1havebeenobserved.TheWesternBlottechniquedisprovesthe

results.ThetransientfalsepositivereactionscouldbeduetotheIgMresponsebythevaccine.

4.6Pregnancyandlactation

Notapplicable.

4.7Effectsonabilitytodriveandusemachines

Thevaccineisunlikelytoproduceanyeffectontheabilitytodriveandusemachines.

4.8Undesirableeffects

Ahigherincidenceofmildpost-immunisationreactionshasbeenreportedwithAddiflucomparedtonon-adjuvanted

influenzavaccines.

Adversereactionsfromclinicaltrials.

ThesafetyofAddifluisassessedinopenlabel,uncontrolledclinicaltrialsperformedasannualupdaterequirement,

includingatleast50elderlyaged65yearsorolder.Safetyevaluationisperformedduringthefirst3daysfollowing

vaccination.

Undesirableeffectsreportedarelistedaccordingtothefollowingfrequency.

Adverseeventsfromclinicaltrials:

Common(>1/100,<1/10):

Localreactions:redness,swelling,painattheinjectionsite,ecchymosis,induration.

Systemicreactions:fever,malaise,shivering,fatigue,headache,sweating,myalgia,arthralgia.

Thesereactionsusuallydisappearwithin1-2dayswithouttreatment.

FromPost-marketingsurveillanceadditionally,thefollowingadverseeventshavebeenreported:

Uncommon(>1/1,000,<1/100):

Generalisedskinreactionsincludingpruritus,urticariaornon-specificrash.

Rare(>1/10,000,<1/1,000):

Neuralgia,paraesthesia,convulsions,transientthrombocytopenia.

Allergicreactions,inrarecasesleadingtoshock,havebeenreported.

Veryrare(<1/10,000):

Vasculitiswithtransientrenalinvolvementandexudativeerythemamultiforme.Neurologicaldisorderssuchas

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4.9Overdose

Overdosageisunlikelytohaveanyuntowardeffect.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Seroprotectionisgenerallyobtainedwithin2to3weeks.Thedurationofpostvaccinationimmunitytohomologous

strainsortostrainscloselyrelatedtothevaccinestrainsvaries,butitisusually6-12months.

Althoughcomparativefieldefficacytrialshavenotbeenperformed,theantibodyresponsetoAddifluisincreasedwhen

comparedtotheresponsetovaccineswithoutadjuvant,andismostpronouncedforBandA/H3N2influenzaantigens.

Thisincreasedresponseisseenparticularlyinelderlysubjectswithlowpre-immunisationtitreand/orwithunderlying

diseases(diabetesandcardiovascularandrespiratorydiseases)whoareatincreasedriskofcomplicationsofinfluenza

infection.AsimilarimmunogenicityprofilehasbeennotedafterasecondandthirdimmunisationwithAddiflu.

SignificantantibodyrisesafterimmunisationwithAddifluhavealsobeenshownagainstheterovariantstrains,

antigenicallydifferentfromthoseincludedinthevaccine.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardforhumansbasedonconventionalstudiesofrepeated-dosetoxicity,

genotoxicityandlocaltolerance.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Adjuvant:seesection2,QualitativeandQuantitativecomposition.

Other:sodiumchloride,potassiumchloride,potassiumdihydrogenphosphate,disodiumphosphatedihydrate,

magnesiumchloridehexahydrate,calciumchloridedihydrateandwaterforinjections.

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3ShelfLife

1year.

6.4Specialprecautionsforstorage

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

6.5Natureandcontentsofcontainer

0.5mlofsuspensionforinjectioninpre-filledsyringe(typeIglass),presentedwithorwithoutneedle.

Packof1,withorwithoutneedle.

Irish Medicines Board

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Date Printed 21/08/2009 CRN 2067720 page number: 4

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Thevaccineshouldbeallowedtoreachroomtemperaturebeforeuse.Thevaccineisamilky-whitesuspension.Gently

shakebeforeuse.

7MARKETINGAUTHORISATIONHOLDER

SanofiPasteurMSDS.p.A.,

ViaDegliAldobrandeschi15,

1-00163Rome,

Italy.

8MARKETINGAUTHORISATIONNUMBER

PA0973/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01September2000

Dateoflastrenewal:08June2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 21/08/2009 CRN 2067720 page number: 5