BEGRIVAC

Main information

  • Trade name:
  • BEGRIVAC Suspension for Injection 15/15/15mc %v/v
  • Dosage:
  • 15/15/15mc %v/v
  • Pharmaceutical form:
  • Suspension for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BEGRIVAC Suspension for Injection 15/15/15mc %v/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0877/001/001
  • Authorization date:
  • 03-04-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Begrivac2010/2011suspensionforinjection

Influenzavaccine(splitvirion,inactivated)

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Influenzavirus(inactivated,split)ofthefollowingstrains*

A/California/7/2009(H1N1)–derivedstrainused

NYMCX-181 15.0microgramsHA**

A/Perth/16/2009(H3N2)–likestrainused 15.0microgramsHA**

NYMCX-187–derivedfromA/Victoria/210/2009

B/Brisbane/60/2008–derivedstrainused 15.0microgramsHA**

NYMCBX-35

per0.5mldose

*propagatedinfertilizedheneggsfromhealthychickenflocks,purified,splitbytween-ether,inactivatedby

formaldehyde

**haemagglutinin

ThevaccinecomplieswiththeWHOrecommendation(northernhemisphere)andEUdecisionforthe2010/2011

season.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Suspensionforinjectioninpre-filledsyringe.

Slightlyopalescent.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Prophylaxisofinfluenza,especiallyinthosewhorunanincreasedriskofassociatedcomplications.

TheuseofBegrivac2010/2011shouldbebasedonofficialrecommendations.

4.2Posologyandmethodofadministration

Adultsandchildrenfrom36months:0.5ml.

Childrenfrom6monthsto35months:Clinicaldataarelimited.Dosagesof0.25mlor0.5mlhavebeenused.

Forchildrenwhohavenotpreviouslybeenvaccinated,aseconddoseshouldbegivenafteranintervalofatleast4

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Immunisationshouldbecarriedoutbyintramuscularordeepsubcutaneousinjection.

Forinstructionsforpreparation,seesection6.6.

4.3Contraindications

Hypersensitivitytotheactivesubstances,toanyoftheexcipientsandtoeggs,chickenprotein,formaldehyde,

diethyleterorpolysorbate80.

Begrivac2010/2011doesnotcontainmorethan1.0µgovalbuminperdose.Thevaccinemaycontainresiduesof

polymyxinB.

Immunisationshallbepostponedinpatientswithfebrileillnessoracuteinfection.

4.4Specialwarningsandprecautionsforuse

Aswithallinjectablevaccines,appropriatemedicaltreatmentandsupervisionshouldalwaysbereadilyavailablein

caseofananaphylacticeventfollowingtheadministrationofthevaccine.

Begrivac2010/2011shouldundernocircumstancesbeadministeredintravascularly.

Antibodyresponseinpatientswithendogenousoriatrogenicimmunosuppressionmaybeinsufficient.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Begrivac2010/2011maybegivenatthesametimeasothervaccines.Immunisationshouldbecarriedoutonseparate

limbs.Itshouldbenotedthattheadversereactionsmaybeintensified.

Theimmunologicalresponsemaybediminishedifthepatientisundergoingimmuno-suppressanttreatment.

Followinginfluenzavaccination,falsepositiveresultsinserologytestsusingtheELISAmethodtodetectantibodies

againstHIV1,HepatitisCandespeciallyHTLV1havebeenobserved.TheWesternBlottechniquedisprovesthefalse-

positiveELISAtestresults.ThetransientfalsepositivereactionscouldbeduetotheIgMresponsebythevaccine.

4.6Fertility,pregnancyandlactation

Thelimiteddatafromvaccinationsinpregnantwomendonotindicatethatadversefetalandmaternaloutcomeswere

attributabletothevaccine.Theuseofthisvaccinemaybeconsideredfromthesecondtrimesterofpregnancy.For

pregnantwomenwithmedicalconditionsthatincreasetheirriskofcomplicationsfrominfluenza,administrationofthe

vaccineisrecommended,irrespectiveoftheirstageofpregnancy.

Begrivac2010/2011maybeusedduringlactation.

4.7Effectsonabilitytodriveandusemachines

Thevaccineisunlikelytoproduceaneffectontheabilitytodriveandusemachines.

4.8Undesirableeffects

Adversereactionsobservedfromclinicaltrials

Thesafetyoftrivalentinactivatedinfluenzavaccinesisassessedinopenlabel,uncontrolledclinicaltrialsperformedas

annualupdaterequirement,includingatleast50adultsaged18–60yearsofageandatleast50elderlyaged61years

orolder.Safetyevaluationisperformedduringthefirst3daysfollowingvaccination.

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Verycommon(>1/10);common( ≥1/100,<1/10);uncommon(≥1/1,000,<1/100);rare(≥1/10,000,<1/1,000);very

rare(<1/10,000),includingisolatedreports.

Nervoussystemdisorders

Common:Headache*

Skinandsubcutaneoustissuedisorders

Common:Sweating*

Musculoskeletalandconnectivetissuedisorders

Common:Myalgia,arthralgia*

Generaldisordersandadministrationsiteconditions

Common:Fever,malaise,shivering,fatigue.Localreactions:redness,swelling,pain,ecchymosis,induration.*

*Thesereactionsusuallydisappearwithin1-2dayswithouttreatment.

Adversereactionsreportedfrompost-marketingsurveillance

Adversereactionsreportedfrompost-marketingsurveillanceare,nexttothereactionswhichhavealsobeenobserved

duringtheclinicaltrials,thefollowing:

Bloodandlymphaticsystemdisorders:

Transientthrombocytopenia,transientlymphadenopathy

Immunesystemdisorders:

Allergicreactions,inrarecasesleadingtoshock,angioedema

Nervoussystemdisorders:

Neuralgia,paraesthesia,febrileconvulsions,neurologicaldisorders,suchasencephalomyelitis,neuritisandGuillain

Barrésyndrome

Vacsulardisorders:

Vasculitisassociatedinveryrarecaseswithtransientrenalinvolvement.

Skinandsubcutaneoustissuedisorders:

Generalisedskinreactionsincludingpruritus,urticariaornon-specificrash.

4.9Overdose

Irish Medicines Board

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Influenzavaccine

ATC-Code:J07BB02

Seroprotectionisgenerallyobtainedwithin2to3weeks.Thedurationofpostvaccinalimmunitytohomologousstrains

ortostrainscloselyrelatedtothevaccinestrainsvariesbutisusually6-12months.

5.2Pharmacokineticproperties

Notapplicable

5.3Preclinicalsafetydata

Notapplicable

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Buffersolution(pH=7.2)containing:sodiumchloride,potassiumchloride,magnesiumchloridehexahydrate,

disodiumphosphatedihydrate,potassiumdihydrogenphosphateandwaterforinjections.

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3ShelfLife

1year

6.4Specialprecautionsforstorage

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

6.5Natureandcontentsofcontainer

0.5mlsuspensioninpre-filledsyringe(TypeIglass)withplungerstopper(bromobutylrubber)withorwithoutneedle

–inpacksizesof1,10or20(2 ×

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Thevaccineshouldbeallowedtoreachroomtemperaturebeforeuse.

Shakebeforeuse.

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7MARKETINGAUTHORISATIONHOLDER

NovartisVaccinesandDiagnosticsGmbH

P.O.Box1630

D-35006Marburg

Germany

8MARKETINGAUTHORISATIONNUMBER

PA0877/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:3April1998

Dateoflastrenewal:30December2007

10DATEOFREVISIONOFTHETEXT

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