Poulvac

Main information

  • Trade name:
  • Poulvac Bursa Plus Lyophilisate for suspension in drinking water
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Poulvac Bursa Plus Lyophilisate for suspension in drinking water
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Avian infectious bursal disease virus (Gumboro disease)
  • Therapeutic area:
  • Chicken Broilers

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0335/001
  • Authorization date:
  • 08-04-2011
  • EU code:
  • UK/V/0335/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:July2013

AN:00576/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PoulvacBursa(DK)

PoulvacBursaPlusvakcinaA.U.V.(HU)

PoulvacBursaPlus(allothercountries)

Lyophilisateforsuspensionindrinkingwater.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance Perdose

LiveInfectiousBursalDiseaseVirus,strainV87710 2.2 -10 3.4 EID

*

50%egginfectivedose

Excipients

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Lyophilisateforsuspensionindrinkingwater.

Appearance:brownishtablets.

4. CLINICALPARTICULARS

4.0 TargetSpecies

Chickens,from10daysofage.

4.1 Indicationsforuse

Fortheactiveimmunisationofchickenswithmaternalantibodylevelsof≤500

ELISAunits,toreducemortalityandbursallesionsofGumborodisease.

Theonsetofimmunityhasbeenshownbychallengefrom14daysafter

vaccinationandthedurationofimmunityis32days.

4.2 Contra-Indications

Donotvaccinatesickbirds.

Donotuseininfectedflocksshowingclinicalsigns.

4.3 SpecialWarnings

Useonlyinflockswithmaternalantibodylevelsof≤500ELISAunits.The

optimumdayofvaccinationiscalculatedaccordingtotheKouwenhoven’s

formula(seesection4.5.Specialprecautionsforuse).

Duetoitsresidualpathogenicitytothebursaethevaccineshouldbeused

onlyincaseofoutbreaksofveryvirulentIBDVstrains.

Revised:July2013

AN:00576/2012

Page2of5

4.4 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

UsecarefullyasPoulvacBursaPlusspreadsfrombirdtobirdandmayalso

spreadtonearbyflocks.Reversiontovirulencestudiesconductedatthe

laboratoryleveldemonstratedthatthereisnoincreaseinvirulenceafter5

passagesinchickens.However,itisrecommendedtoavoidspreading,

especiallytolayingbirds.

Theoptimumageforvaccinationmaybedeterminedwiththefollowing

method:

DeterminetheELISA*antibodytitresagainstGumboroDiseasein20

chickensof1dayofage.

Foreachresult,calculatethesquareroot.

Calculatetheaveragesquarerootforalldata(M).

Theageforvaccination(J)iscalculatedwiththeformula:

J=1+(M-22.36)

2.82

*MethodvalidfordatacollectedwiththeIdexxFlockChek®:Anti-IBDassay

kit.

Whateverthevaccinationdaycalculationreaches,donotvaccinatebirdsless

than10daysofage.

ii) Specialprecautionstobetakenbythepersonadministeringthe

medicinalproducttoanimals

Washanddisinfecthandsandequipmentaftervaccination.

iii) Otherprecautions

None

4.5 Adversereactions(frequencyandseriousness)

Theadministrationofasingledoseto10-dayoldchickenscauseslymphocyte

depletioninthebursaofFabricius(in75-100%ofthefollicles).Lymphocyte

repopulationisobservedfrom21dayspostvaccinationonwards.At28days

postvaccinationthereisstilldepletionremaining(25-75%offollicles).Asa

consequencevaccinationwithPoulvacBursaPlusmayinduce

immunosuppression.

4.6 Useduringpregnancy,lactationorlay

Donotuseinlayingorbreedinghens.

4.7 Interactionswithothermedicinalproductsandotherformsof

interaction

InteractionwithvaccinationagainstNewcastleDiseasehasbeenstudied.No

Revised:July2013

AN:00576/2012

Page3of5

significantinterferenceinprotectionagainstNewcastleDiseasevirusvirulent

challengeisobservedinbirdsvaccinatedat10daysofagewithPoulvac

BursaPlusand7dayslaterwithaliveNewcastlediseasevaccine.However,a

statisticallylowerserologicalresponsetoNewcastleDiseaseviruswas

observedinbirdsvaccinatedwithPoulvacBursaPlus.Asaconsequencea

transientimmunodepressionfollowingvaccinationwithPoulvacBursaPlus

cannotbeexcluded.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhen

usedwithanyotherveterinarymedicinalproduct.Adecisiontousethis

vaccine

beforeorafteranyotherveterinarymedicinalproductthereforeneedstobe

madeonacasebycasebasis.

4.8 Amountstobeadministeredandadministrationroute

Onedoseperchickentobeadministeredwithdrinkingwaterfrom10daysof

age.

Makesurethatallconduitpipes,tubing,troughs,drinkersetcarethoroughly

cleanandfreeofanytraceofdisinfectants,detergents,soap,etc.

Allowwatertobeconsumedsothatlevelsindrinkersareminimalbefore

vaccineisapplied.Ifwaterisstillpresent,drainlinesbeforeapplyingvaccine.

Applyvaccineoverupto3hours,ensuringthatallbirdsdrinkduringthistime.

Birds’drinkingbehaviourvaries.Itmaybenecessarytowithholdwateron

somesitespriortovaccinationinordertoensurethatallbirdsdrinkduringthe

vaccinationperiod.Theaimistogiveeverybirdonedoseofvaccine.

Waterusedfordrinkingwateradministrationofalivevirusvaccinemustbe

non-chlorinatedandcontainasfewaspossiblemetalions.Thiscanbe

achievedbyallowingmainswatertostandfor12hoursorbyuseofdeionised

water.Theadditionofmilkpowder(low-fatskimmedmilkpowder,<1%fat,2-

4gramsperlitre)orskimmedmilk(1litreper40litresofwater)is

recommendedwherethisisnotpossibletoincreasethestabilityofthevirus.

Openthevaccineampouleunderwateranddissolvethoroughly.Asthe

concentratedvaccineisslightlyviscous,careshouldbetakentoemptythe

ampouleanditstopcompletelybyrinsingtheminwater.Then,thoroughly

dissolveina1litrecontainerandstirwellbeforemixingwithmorewaterina

10-litrecontainerbeforeapplication.Vaccinemustbestirredthoroughlyfor

severalminutesateachstage.Donotsplitlargevialstovaccinatemorethan

1houseordrinkingsystem,asthisleadstomixingerrors.Applydiluted

vaccinetocoldandfreshwaterattherateof1,000dosesofthevaccineto1

litreofwaterperdayofagefor1,000chickens,e.g.10litreswouldbeneeded

for1,00010-dayoldchickens.

Alltubingshouldbeemptiedofplainwater,sothatthedrinkerscontainonly

vaccinewater.Ideallyvaccineshouldbeadministeredinthevolumeofwater

consumedbythebirdsinupto3hours.Ifindoubt,measurewaterintakethe

daybeforeadministeringvaccine.

Administerthedissolvedvaccinetobirdsimmediatelyafterdilution.

Avoidexposureofthevaccinesuspensiontosunlight.

Avoidstressinthebirdsaroundvaccination.

Revised:July2013

AN:00576/2012

Page4of5

4.9 Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Afteradministrationofa10xoverdose,nootheradversereactionsthanthose

reportedatsection4.6“Adversereactions”areobserved.

4.10Withdrawalperiod

ZeroDays

5. IMMUNOLOGICALPROPERTIES

TostimulateactiveimmunityagainstInfectiousBursalDisease(Gumboro

disease)Virus.

ThevaccinestrainV877isclassifiedasanIntermediatePlusIBDVvaccine

strain.

VaccinestrainV877inducesalesionscoreofaround2.7tothebursaof

Fabriciusobserved28daysafteradministrationof50maximumdosesto

10-dayoldchickens.

ATCVetcode:QI01AD09

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sucrose

Sodiumdihydrogenphosphate

Dipotassiumphosphate

BovineserumalbuminfractionV

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackageforsale:21months

Shelf-lifeafterreconstitutionaccordingtodirections:usewithin4hours.

6.4 Specialprecautionsforstorage

Storeandtransportrefrigerated(2

C-8

C).

Protectfromlight.

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Bottle:TypeI(Ph.Eur.)glassbottles.

Closure:TypeI(Ph.Eur.)butylrubberstopperssealedwithaluminium

overseal.

PackSizes:1x1000,1x2000,1x5000,10x1000,10x2000or10x5000doses.

Revised:July2013

AN:00576/2012

Page5of5

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinaryproduct

orwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Disposeofwastematerialbyboiling,incinerationorimmersioninan

appropriatedisinfectantapprovedforusebythecompetentauthorities.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLimited

RamsgateRoad

Sandwich

Kent

CT139NJ

8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4411

9. DATEOFFIRSTAUTHORISATION

03February1998

10. DATEOFREVISIONOFTHETEXT

July2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

AMemberStatemay,inaccordancewithitsnationallegislation,prohibitthe

import,possession,sale,supplyand/oruseofPoulvacBursa[Plus]onthe

wholeorpartofitsterritoryifitisestablishedthatthediseasetowhichthe

productisintendedtoconferimmunityislargelyabsentfromtheterritoryin

question.

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