AGRIPPAL

Main information

  • Trade name:
  • AGRIPPAL Suspension for Injection
  • Pharmaceutical form:
  • Suspension for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AGRIPPAL Suspension for Injection
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0919/001/001
  • Authorization date:
  • 19-02-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AGRIPPAL

Suspensionforinjectioninpre-filledsyringe

Influenzavaccine(surfaceantigen,inactivated)

(2011/2012SEASON)

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Influenzavirussurfaceantigens(haemagglutininandneuraminidase),ofthefollowingstrains*:

A/California/07/2009(H1N1)-derivedstrainusedNYMCX-181 15microgramsHA**

A/Perth/16/2009(H3N2)-likestrainusedNYMCX-187derivedfromA/Victoria/210/200915microgramsHA**

B/Brisbane/60/2008 15microgramsHA**

Per0.5mldose

*propagatedinfertilizedhens’eggsfromhealthychickenflocks

**haemagglutinin

ThisvaccinecomplieswiththeWHOrecommendations(northernhemisphere)andEUdecisionforthe

2011/2012season.

Forafulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

Suspensionforinjectioninpre-filledsyringe.

Thevaccineappearsasaclearliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Prophylaxisofinfluenza,especiallyinthosewhorunanincreasedriskofassociated

complications.

TheuseofAGRIPPALshouldbebasedonofficialrecommendations.

4.2Posologyandmethodofadministration

Adultsandchildrenfrom36months:0.5ml

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

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weeks.

Immunisationshouldbecarriedoutbyintramuscularordeepsubcutaneousinjection.

Forinstructionsforpreparation,seesection6.6.

4.3Contraindications

Hypersensitivitytotheactivesubstances,toanyoftheexcipientsandtoresiduese.g.eggs,chickenproteins,suchas

ovalbumin.

Thevaccinemaycontainresiduesofthefollowingsubstances,e.g.kanamycinandneomycinsulphate,formaldehyde

cetyltrimethylammoniumbromide(CTAB)andpolysorbate80.

Immunisationshallbepostponedinpatientswithfebrileillnessoracuteinfection.

4.4Specialwarningsandprecautionsforuse

Aswithallinjectablevaccines,appropriatemedicaltreatmentandsupervisionshouldalwaysbereadilyavailablein

caseofananaphylacticeventfollowingtheadministrationofthevaccine.

AGRIPPALshouldundernocircumstancesbeadministeredintravascularly.

Antibodyresponseinpatientswithendogenousoriatrogenicimmunosuppressionmaybeinsufficient.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

AGRIPPALmaybegivenatthesametimeasothervaccines.Immunisationshouldbecarriedoutonseparatelimbs.It

shouldbenotedthattheadversereactionsmaybeintensified.

Theimmunologicalresponsemaybediminishedifthepatientisundergoing

immunosuppressanttreatment.

Followinginfluenzavaccination,falsepositiveresultsinserologytestsusingtheELISAmethodtodetectantibodies

againstHIV1,HepatitisCandespeciallyHTLV1havebeenobserved.TheWesternBlottechniquedisprovesthefalse-

positiveELISAresults.ThetransientfalsepositivereactionscouldbeduetotheIgMresponsebythevaccine.

4.6Fertility,pregnancyandlactation

Thelimiteddatafromvaccinationsinpregnantwomendonotindicatethatadversefoetalandmaternaloutcomeswere

attributabletothevaccine.Theuseofthisvaccinemaybeconsideredfromthesecondtrimesterofpregnancy.For

pregnantwomenwithmedicalconditionsthatincreasetheirriskofcomplicationsfrominfluenza,administrationofthe

vaccineisrecommended,irrespectiveoftheirstageofpregnancy.

Thevaccine(AGRIPPAL)maybeusedduringlactation.

4.7Effectsonabilitytodriveandusemachines

Thevaccineisunlikelytoproduceaneffectontheabilitytodriveandusemachines.

4.8Undesirableeffects

ADVERSEREACTIONSOBSERVEDFROMCLINICALTRIALS

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annualupdaterequirement,includingatleast50adultsaged18–60yearsofageandatleast50elderlyaged61years

orolder.Safetyevaluationisperformedduringthefirst3daysfollowingvaccination.

Thefollowingundesirableeffectshavebeenobservedduringclinicaltrialswiththefollowingfrequencies:

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

(1/10,000,<1/1,000);veryrare(<1/10,000),includingisolatedreports.

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,pain,ecchymosis,induration.*

*Thesereactionsusuallydisappearwithin1-2dayswithouttreatment.

ADVERSEREACTIONSREPORTEDFROMPOST-MARKETING

SURVEILLANCE

Adversereactionsreportedfrompostmarketingsurveillanceare,nexttothereactionswhichhavealsobeenobserved

duringtheclinicaltrials,thefollowing:

Bloodandlymphaticsystemdisorders

Transientthrombocytopenia,transientlymphadenopathy.

Immunesystemdisorders

Allergicreactions,inrarecasesleadingtoshock,angioedema

Nervoussystemdisorders

Neuralgia,paraesthesiae,febrileconvulsions,neurologicaldisorders,suchasencephalomyelitis,neuritisandGuillain-

Barrésyndrome.

Vasculardisorders

Vasculitisassociatedinveryrarecaseswithtransientrenalinvolvement

Skinandsubcutaneoustissuedisorders

Generalisedskinreactionsincludingpruritus,urticariaornon-specificrash.

4.9Overdose

Overdosageisunlikelytohaveanyuntowardeffect.

5PHARMACOLOGICALPROPERTIES

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Pharmacotherapeuticgroup:Influenzavaccine,ATCcode:J07BB02.

Seroprotectionisgenerallyobtainedwithin2to3weeks.Thedurationofpostvaccinal

immunitytohomologousstrainsortostrainscloselyrelatedtothevaccinestrainsvariesbutisusually6-12months.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

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

0.5mlofsuspensioninpre-filledsyringe(typeIglass)withneedle(23G,1”or25G,1”or25G,5/8”),equippedwith

arubberplungerstopper–packsizeof1or10.

0.5mlofsuspensioninpre-filledsyringe(typeIglass)withoutneedle,equippedwitharubberplungerstopper–pack

sizeof1or10.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Thevaccineshouldbeallowedtoreachroomtemperaturebeforeuse.

Shakebeforeuse.

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syringebarrel),beforeinjection.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisVaccinesandDiagnosticsS.r.l.

ViaFiorentina1

53100Siena

Italy

8MARKETINGAUTHORISATIONNUMBER

PA0919/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 19February1999

Dateoflastrenewal: 18February2009

10DATEOFREVISIONOFTHETEXT

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