Poulvac

Main information

  • Trade name:
  • Poulvac Ibmm + Ark Vaccine
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Poulvac Ibmm + Ark Vaccine
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Chicken

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0180/001
  • Authorization date:
  • 15-09-2011
  • EU code:
  • UK/V/0180/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:July2013

AN:00938/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

POULVACIBMM+ARK –PowderfornebulisersolutionforBroilerchickens

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Quantitativecomposition

ActiveSubstances:

GlobalAmountperDose

AvianInfectiousBronchitisVirus

(StrainMassachusetts1263and

StrainArkansas3168)

3.3

*

*EID

:Embryoinfectivedose50%

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Powderfornebulisersolution

4. CLINICALPARTICULARS

4.1Targetspecies

Broilerchickens

4.2Indicationsforuse,specifyingthetargetspecies

Fortheactiveimmunisationofchickenstoreducetheseverityofupper

respiratorytractinfectionscausedbyMassachusettsand793/B/91-typestrains

ofAvianInfectiousBronchitisvirus.

Theonsetofimmunityisfromthreeweekspostvaccinationandlastsforsix

weekspostvaccination.

Revised:July2013

AN:00938/2012

Page2of5

Protectionhasalsobeendemonstratedinthepresenceofmaternallyderived

antibody.

4.3Contraindications

Donotuseinunhealthybirds.

Donotre-vaccinatebirds.

Donotuseduringthelayingperiodorinbirdsintendedforlayingorbreeding.

Sprayvaccinationshouldnotbeusedifanintercurrentinfectionissuspected.

4.4Specialwarnings

InfectiousBronchitisvirusstrainsMassachusettsandArkansasmayspreadtoin

contactbirds.Thedurationofspreadingofthevaccinevirusisforupto30days

followingvaccination.

Itisrecommendedthatallchickensonasitebevaccinatedwiththisproduct.

Donotuseonmixedsitesofbroilersandbreeders.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Donotvaccinatediseasedbirds.

Theproductshouldonlybeusedwhereithasbeenestablishedthat793/B/91

likeinfectiousbronchitisserotypesareepidemiologicallyrelevantinthearea.

Careshouldbetakentoavoidspreadofthevaccinevirusfromvaccinatesto

pheasants

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Forthesafetyofeyes,noseandmouth,theuseofsafetygogglesanddustmask

isrecommended.Ahelmetwithfilteredaircirculationmaybeusedinsteadof

gogglesandmask.

4.6Adversereactions(frequencyandseriousness)

Aslighttransientrespiratoryreaction,includinggasping,snickingandraling,may

beobservedatarateofapproximately10%ofvaccinatedbirdsforapproximately

threedays.

4.7Useduringpregnancy,lactationorlay

Donotuseinbirdsintendedforlayingorbreeding.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenused

withanyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebefore

orafteranyotherveterinarymedicinalproductthereforeneedstobedecidedon

acasebycasebasis

Revised:July2013

AN:00938/2012

Page3of5

4.9Amountstobeadministeredandadministrationroute

Coarsesprayvaccinationfromonedayofage.

CoarseSpray:

Thisvaccinehasbeenusedinmosttypesofsprayequipmenthandsprayers(e.g.

ASLPolyspray2),knapsacksprayers(e.g.Birchmeyerwith0.55or1.6mm

spraynozzle,Gloriawith1.0mmnozzle)orautomaticsprayingequipment(e.g.

Bimex).Theapparatusshouldbesettodeliveracoarsespray(dropletsizeof

80-160microns),allowingadoseof0.5mlperbird

Thevaccineshouldbereconstitutedwithwaterofgoodqualityatroom

temperaturee.g.deionisedwaterorgoodqualitydrinkingwater.

Thevaccineshouldbedissolvedasfollows:

Removethealuminiumsealfromthevaccinevial.Todissolvethevaccinepellet,

therubberstoppershouldthenberemovedwhilstthevialisimmersedina

plasticmeasuringjugcontaining0.5litreofcleancoolwater.

Halffillthevialwithwater,replacethestopperandshaketodissolveany

remainingvaccine.

Thevaccineconcentrateshouldthenbeaddedtothewaterinthejug,mixedwell

andtransferredtothesprayertankandthoroughlymixed.Forthe1000dosevial

atotalamountof0.5lwatershouldbeused.Forthe5000dosevialatotal

amountof2.5lwaterisrequiredandforthe10,000dosevialatotalamountof5l

watershouldbeused.

Thechickensshouldbesprayedinchickboxesorcartonringsinthehouseto

avoidlossofthevaccinevirus.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Aslighttransientrespiratoryreaction,includinggasping,snickingandraling,may

beobservedatarateofapproximately10%ofvaccinatedbirdsforapproximately

threedays.

4.11Withdrawalperiod(s)

Zerodays

5. IMMUNOLOGICALPROPERTIES

Tostimulateactiveimmunityagainstavianinfectiousbronchitis,strains

Massachusettstypeand793/B/91like(Arkansas)

ATCVetCode:QI01AD07

Revised:July2013

AN:00938/2012

Page4of5

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Pharmatone

Bacto-Peptone

Sucrose

N-ZAmineYT

Monosodiumglutamate

6.2Incompatibilities

Donotmixwithanyothermedicinalproduct.

6.3Shelflife

2yearsforthefreezedriedvaccine

Shelf-lifeafterreconstitutionaccordingtodirections:2hours

6.4.Specialprecautionsforstorage

Storeandtransportrefrigerated(2ºC –8ºC).

Protectfromlight.

Donotfreeze

6.5Natureandcompositionofimmediatepackaging

Nature:HydrolytictypeIglassvialswithabutylrubber(PhEur)stopperand

aluminiumcap.

Content:

6mlglassvialcontaining1,000doses(Packof10vials)

10mlglassvialcontaining5,000doses(Packof10vials)

20mlglassvialcontaining10,000doses(Packof10vials)

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriate

disinfectantinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

Revised:July2013

AN:00938/2012

Page5of5

8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4380

9. RENEWALOFAUTHORISATION

02July2008

10.DATEOFREVISIONOFTHETEXT

July2013

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