FLUVIRIN (INACTIVATED INFLUENZA VACCINE)

Main information

  • Trade name:
  • FLUVIRIN (INACTIVATED INFLUENZA VACCINE)
  • Pharmaceutical form:
  • Suspension for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLUVIRIN (INACTIVATED INFLUENZA VACCINE)
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1001/005/001
  • Authorization date:
  • 14-08-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Fluvirin,Suspensionforinjectioninpre-filledsyringe.[InfluenzaVaccine(Surfaceantigen,

Inactivated)Ph.Eur.]

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Influenzavirussurfaceantigens(haemagglutininandneuraminidase)propagatedinembryonated

chickeneggs,inactivatedbybetapropiolactone,splitbynonoxynol9andpurified,ofstrains:

ThisvaccinecomplieswiththeWHOrecommendation(northernhemisphere)andEUdecisionforthe

year2004/2005.

Forexcipientssee6.1.

3PHARMACEUTICALFORM

Suspensionforinjectioninpre-filledsyringe

4CLINICALPARTICULARS

4.1TherapeuticIndications

Prophylaxisofinfluenza,especiallyinthosewhorunanincreasedriskofassociatedcomplications.

4.2Posologyandmethodofadministration

Adultsandchildrenfrom4years:0.5ml.

Forchildrenwhohavenotpreviouslybeenvaccinated,aseconddoseshouldbegivenafteraninterval

ofatleast4weeks.

A/NewCaledonia/20/99(H1N1)-likestrain

(A/NewCaledonia/20/99(IVR-116))Ph.Eur. 15micrograms**Haemagglutinin

A/Fujian/411/2002(H3N2)–likestrain

(A/Wyoming/3/2003X-147) 15micrograms**Haemagglutinin

B/Shanghai/361/2002-likestrain

(B/Jiangsu/10/2003) 15micrograms**Haemagglutinin

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4.3Contraindications

Hypersensitivitytotheactivesubstances,toanyoftheexcipientsandtoeggs,chickenproteins,

betapropiolactone,nonoxynol9,neomycin,polymyxin,formaldehyde,orthiomersal.

Immunisationshallbepostponedinpatientswithfebrileillnessoracuteinfection.

4.4Specialwarningsandprecautionsforuse

Aswithallinjectablevaccines,appropriatemedicaltreatmentandsupervisionshouldalwaysbe

readilyavailableincaseofarareanaphylacticeventfollowingtheadministrationofthevaccine.

Thevaccine(FLUVIRIN®)shouldundernocircumstancesbeadministeredintravascularly.

Antibodyresponseinpatientswithendogenousoriatrogenicimmunosuppressionmaybeinsufficient.

Thiomersal(anorganomercuriccompound)hasbeenusedinthemanufacturingprocessofthis

medicinalproductandresiduesofitarepresentinthefinalproduct.Thereforesensitisationreactions

mayoccur.ThemaximumthiomersalcontentinFLUVIRIN is0.005mg(0.001%w/v).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thevaccine(FLUVIRIN®)maybegivenatthesametimeasothervaccines.Immunisationshouldbe

carriedoutonseparatelimbs.Itshouldbenotedthattheadversereactionsmaybeintensified.

Theimmunologicalresponsemaybediminishedifthepatientisundergoingimmunosuppressant

treatment.

Followinginfluenzavaccination,falsepositiveresultsinserologytestsusingtheELISAmethodto

detectantibodiesagainstHIV1,HepatitisCandespeciallyHTLV1havebeenobserved.TheWestern

Blottechniquedisprovestheresults.ThetransientfalsepositivereactionscouldbeduetotheIgM

responsebythevaccine.

4.6Pregnancyandlactation

Limiteddatafromvaccinationsinpregnantwomendonotindicatethatadversefoetalandmaternal

outcomeswereattributabletothevaccine.Theuseofthisvaccinemaybeconsideredfromthesecond

trimesterofpregnancy.Forpregnantwomenwithmedicalconditionsthatincreasetheirriskof

complicationsfrominfluenza,administrationofthevaccineisrecommended,irrespectiveoftheir

stageofpregnancy.

Thevaccine(FLUVIRIN®)maybeusedduringlactation.

4.7Effectsonabilitytodriveandusemachines

Thevaccineisunlikelytoproduceaneffectontheabilitytodriveandusemachines.

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Adversereactionsfromclinicaltrials.Thesafetyoftrivalentinactivatedinfluenzavaccinesisassessed

inopenlabel,uncontrolledclinicaltrialsperformedasannualupdaterequirement,includingatleast

50adultsaged18-60yearsofageandatleast50elderlyaged60yearsorolder.Safetyevaluationis

performedduringthefirst3daysfollowingvaccination.

Undesirableeffectsreportedarelistedaccordinglytothefollowingfrequency.

Adverseeventsfromclinicaltrials:

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

Localreactions:Redness,swelling,pain,ecchymosis,induration.

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

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FromPost-marketingsurveillanceadditionally,thefollowingadverseeventshavebeenreported:

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

Gereralisedskinreactionsincludingpruritus,urticariaornon-specifiocrash.

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

Neuralgia,paraesthesia,convulsions,transientthrombocytopenia.

Allergicreactions,inrarecasesleadingtoshock,havebeenreported.

Veryrare(<1/10,000):

Vasculitiswithtransientrenalinvolvement.

Neurologicaldisorders,suchasencephalomyelitis,neuritisandGuillainBarrésyndrome.

4.9Overdose

Overdosageisunlikelytohaveanyuntowardeffect.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Seroprotectionisgenerallyobtainedwithin2to3weeks.Thedurationofpostvaccinalimmunityto

homologousstrainsortostrainscloselyrelatedtothevaccinestrainsvariesbutisusually

6-12months.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Buffersolution:

Potassiumdihydrogenphosphate

Disodiumhydrogenphosphate

Sodiumchloride

Waterforinjection

6.2Incompatibilities

Irish Medicines Board

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products.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Storeat+2°Cto+8°C(inarefrigerator).Donotfreeze.Keepcontainerintheoriginalcarton.

6.5Natureandcontentsofcontainer

0.5mlinpre-filledsyringe(glass,type1)withstopper(rubber),fittedwithastainlesssteelneedle,

packof1,10,20and50syringes.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerials

derivedfromsuchmedicinalproductandotherhandlingoftheproduct

Thevaccineshouldbeallowedtoreachroomtemperaturebeforeuse.Shakebeforeuse.

7MARKETINGAUTHORISATIONHOLDER

ChironVaccinesLimited

GaskillRoad

Speke

Liverpool

L249GR

8MARKETINGAUTHORISATIONNUMBER

PA1001/5/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14August1998

Dateoflastrenewal:30December2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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