Porcilis PRRS

Main information

  • Trade name:
  • Porcilis PRRS
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Porcilis PRRS
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic area:

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0145/001
  • Authorization date:
  • 16-12-2011
  • EU code:
  • UK/V/0145/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:December2011

AN:00178/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PorcilisPRRS

Lyophilisateandsolventforsuspensionforinjectionforpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perdoseof2ml(intramuscularapplication)or0.2ml(intradermalapplication)of

reconstitutedvaccine:

Lyophilisate:

Activesubstance:

LiveattenuatedPRRSvirusstrainDV:10 4.0

-10 6.3

TCID

Solvent(DiluvacForte):

Adjuvant:

-tocopherylacetate:75mg/ml

Forafulllistofexcipients,seesection6.1.

tissuecultureinfectivedose50%

3. PHARMACEUTICALFORM

Lyophilisateandsolventforsuspensionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs.

4.2 Indicationsforuse,specifyingthetargetspecies

ForactiveimmunisationofclinicallyhealthypigsinaPRRSviruscontaminated

environment,toreduceviraemiacausedbyinfectionwithEuropeanstrainsofPRRS

virus.

Specificclaims

Forfinishingpigs,theeffectofthevirusontherespiratorysystemismostrelevant.

Asignificantimprovementofrearingresults(reducedmorbidityduetoPRRS

infection,andabetterdailygrowthandfeedconversion)untiltheendofthe

fatteningperiodwasobservedinvaccinatedpigsduringfieldtrials,particularlyin

pigletsvaccinatedat6weeksofage.

Forbreedingpigs,theeffectofthevirusonthereproductivesystemismost

relevant.AsignificantimprovementofthereproductiveperformanceinPRRSvirus

contaminatedenvironmentsandareductionoftransplacentalvirustransmission

afterchallengewasobservedinvaccinatedpigs.

Revised:December2011

AN:00178/2011

TheinterestofvaccinationwithPorcilisPRRSliesinobtainingahomogeneousand

highimmunestatusagainstPRRSvirusinaherd.

Immunityhasbeendemonstratedviachallengeat28dayspostvaccination.A

durationofimmunityofatleast24weekshasbeendemonstrated.

4.3 Contraindications

DonotuseinherdswheretheprevalenceofEuropeanPRRSvirushasnotbeen

establishedthroughreliablediagnosticmethods.

4.4 Specialwarningsforeachtargetspecies

PorcilisPRRSmustonlybeusedinPRRSviruscontaminatedherds,where

prevalenceofEuropeanPRRSvirushasbeenestablishedthroughreliable

diagnosticvirologicalmethods.Nodataareavailableonthesafetyofthevaccine

forthereproductiveperformanceinboars.DonotuseinherdswhereaPRRS

eradicationprogrammebasedonserologyhasbeenadopted.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Careshouldbetakentoavoidtheintroductionofthevaccinestrainintoanarea

wherePRRSvirusisnotalreadypresent.Thevaccinevirusmayspreadtopigs

incontactduring5weeksaftervaccination.Themostcommonspreadingroute

isviadirectcontact,butspreadingviacontaminatedobjectsorviatheair

cannotbeexcluded.Careshouldbetakentoavoidspreadofvaccinevirusfrom

vaccinatedanimalstounvaccinatedanimals(e.g.:naïvepregnantsows)that

shouldremainfreefromPRRSvirus.Donotuseinboarsproducingsemenfor

seronegativeherds,asPRRSvirusmaybeexcretedinsemenformanyweeks.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshow

thepackageleafletorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

Systemicorlocalreactionsmaybeobservedaftervaccination.Afterintramuscular

vaccinationatransienthyperthermiamayoccur.Inrarecasesthevaccinationcan

evokehypersensitivityreactionssuchasdyspnoea,hyperaemia,decubitus,tremor,

excitationandvomiting.Thesesignsnormallydisappearspontaneouslyandtotally

withinafewminutesaftervaccination,however,inveryrarecasesfatal

anaphylacticreactionshaveoccurred.

Asmallfirmintradermallump(1.5cmindiametermaximally)observedafterthe

intradermalapplicationisindicativeoftheappropriatevaccinationtechnique.This

dermallumpisgenerallyseenforlessthan14daysbutmayoccasionallypersistfor

29daysorlonger.

Revised:December2011

AN:00178/2011

4.7 Useduringpregnancy,lactationorlay

PRRSvirus-naïvegiltsandsowsshouldnotbevaccinatedduringpregnancy,as

thiscanhavenegativeeffects.Vaccinationduringpregnancyissafewhenitis

performedingiltsandsowswhicharealreadyimmunizedagainstEuropeanPRRS

virusviavaccinationorfieldinfection.Thevaccinecanbeusedduringlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Safetyandefficacydataforintramuscularinjectionareavailableinfinishingpigs

from4weeksofageonwards,whichdemonstratethatthisvaccinecanbemixed

withPorcilisMHyo.

TheproductliteratureofPorcilisMHyoshouldbeconsultedbeforeadministrationof

themixedproduct.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwith

anyotherveterinarymedicinalproductexcepttheproductmentionedabove.A

decisiontousethisvaccinebeforeorafteranyotherveterinarymedicinalproduct

thereforeneedstobemadeonacasebycasebasis.

NoinformationisavailableonthesafetyandefficacyoftheuseofPorcilisPRRS

mixedwithPorcilisMHyoinbreedinganimalsorduringpregnancy.

4.9 Amountstobeadministeredandadministrationroute

Reconstitutethevaccinewiththecorrespondingadjuvantingdiluent(useonly

DiluvacForte).

Number

ofdoses

pervial Volume(ml)ofdiluentneededfor

intramuscular

injection

intradermal

application

10

25

50

100 20

50

100

200 2

5

10

20

Dosage:

Intramuscularinjection:2mlintheneck.

Intradermalapplication:0.2mlontoportotheleftorrightsideoftheneck,oralong

themusclesoftheback,usinganintradermaldevice.

Asmall,transient,intradermallumpobservedaftertheintradermalapplicationis

indicativeoftheappropriatevaccinationtechnique.

Vaccinationscheme:

Asingledoseisgiventopigsfrom2weeksofageonwards.

Finishingpigs: asinglevaccinationissufficientforprotectionuntilslaughter.

Breedingpigs: Forgiltsa(re)vaccination2-4weeksbeforematingis

recommended.

Tomaintainahighandhomologouslevelofimmunity,

revaccinationatregularintervalsisrecommended,eitherbefore

Revised:December2011

AN:00178/2011

eachnextgestationoratrandomat4monthintervals.Pregnant

sowsshouldonlybevaccinatedafterpreviousexposureto

EuropeanPRRSvirus.

Itisadvisedtovaccinatealltargetpigswithinaherdfromtheearliestrecommended

ageonwards.Maternallyderivedantibodiesmayinterferewiththeresponseto

vaccination.

NewlyintroducedPRRSvirus-naïveanimals(e.g.replacementgiltsfromPRRS

virus-negativeherds)shouldbevaccinatedpriortopregnancy.

Thevaccinemaybereconstitutedshortlybeforevaccinationforsimultaneoususe

withPorcilisMHyoinfinishingpigsfrom4weeksofageandthefollowing

instructionsshouldbeused:

PorcilisPRRS PorcilisMHyo

10doses+20ml

25doses+50ml

50doses+100ml

100doses+200ml

Asingledose(2ml)ofPorcilisPRRSmixedwithPorcilisMHyoisgiven

intramuscularlyintheneck.

Usesterilesyringesandneedlesorcleanintradermalequipment.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theeffectsseenafteraten-foldoverdoseofvaccinevirusandatwo-foldoverdose

ofdiluentweresimilartothoseseenafterasingledoseofvaccine.

4.11Withdrawalperiod

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Pig,livePRRSviralvaccine,

ATCvetcode:QI09AD03

IntramuscularorintradermaladministrationofPorcilisPRRSresultsinthe

productionofspecificantibodiesandactiveimmunisationagainstinfectioncaused

byEuropeanstrainsofPorcineReproductiveandRespiratorySyndromevirus.

Immunityisenhancedbytheadjuvantα-tocopherylincludedinthediluentfor

reconstitution.

Onthebasisofantibodiesinducedbyvaccination,itisnotpossibletodiscriminate

vaccinatedanimalsfromthosenaturallyinfectedwithEuropeanstrainsofPRRS

virus.

Revised:December2011

AN:00178/2011

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Freeze-driedvaccine:

culturemedium,

chemicallydefinedstabiliserCD#279(patented)

Solvent(DiluvacForte):

polysorbate80,

sodiumchloride,

potassiumdihydrogenphosphate,

disodiumphosphatedihydrate,

simethicone,

waterforinjection

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct,exceptthediluentsupplied

withtheproductorwithPorcilisMHyo.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale.

Freeze-driedvaccine:

1yea r(afterstoragebythemanufacturerat≤-20°Cduringmaximum12months)

Diluent:

Inglassvials4years,inPETvials2years

Shelflifeafterreconstitutionaccordingtodirections:3hoursatroomtemperature.

AftermixingwithPorcilisMHyo:1houratroomtemperature.

6.4. Specialprecautionsforstorage

Vaccineorcombinedpackaging:storeinarefrigerator(2

C –8

C).Protectfrom

light

Diluent:storebelow25°C.

6.5 Natureandcompositionofimmediatepackaging

Vaccinecontainer:

GlassTypeIvial(Ph.Eur.),closedwithahalogenobutylrubberstopper(Ph.Eur.)

andsealedwithacodedaluminiumcap.

Diluentcontainer:

GlassTypeIIvial(Ph.Eur.)orPET-flask,closedwithahalogenobutylrubber

stopper(Ph.Eur.)andsealedwithacodedaluminiumcap.

IMpresentation:

Solventmaybepackedtogetherwiththelyophilisateorseparately:

Cardboardboxeswith1or10glassvialswith10,25,50or100dosesoffreeze-

driedvaccine

Revised:December2011

AN:00178/2011

Cardboardboxeswith1or10glassorPETvialswith20,50,100or200mlof

DiluvacForte

Cardboardboxeswith1or10glassvialswith10,25,50or100dosesoffreeze-

driedvaccine

plus1or10glassorPETvialswith20,50,100or200mlofDiluvacForte

IDpresentation:

Cardboardboxeswith1or5glassvialswith10,25,50or100dosesoffreeze-dried

vaccineplus1or5glassorPETvialswith2,5,10or20mlofDiluvacForte.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriate

disinfectantapprovedforusebythecompetentauthorities.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.representedby:

IntervetUKLimited

WaltonManor

Walton

MiltonKeynes

Buckinghamshire

MK77AJ

UnitedKingdom

IntervetIrelandLimited

MagnaDrive

MagnaBusinessPark

CitywestRoad

Dublin24

8. MARKETINGAUTHORISATIONNUMBERS

Vm 06376/4027 VPA10996/128/100

9. DATEOFFIRSTAUTHORISATION

Date:21September2000

10. DATEOFREVISIONOFTHETEXT

Date:December2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

29-6-2018

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Active substance: Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)4166 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/3796/II/7

Europe -DG Health and Food Safety