Poulvac Ibmm + Ark Vaccine

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
    Italy
  • 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

APPROVED 4/07/13

1-10-2018

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Active substance: Mycoplasma synoviae Strain MS-H live attenuated thermosensitive) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6404 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/161/T/11

Europe -DG Health and Food Safety

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

22-8-2018

CLYNAV (Elanco GmbH)

CLYNAV (Elanco GmbH)

CLYNAV (Active substance: Salmon pancreas disease vaccine (recombinant DNA plasmid)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5624 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2390/T/02

Europe -DG Health and Food Safety

10-8-2018

Medicines and vaccines post-market vigilance - statistics for 2017

Medicines and vaccines post-market vigilance - statistics for 2017

Post-market vigilance statistics for 2017

Therapeutic Goods Administration - Australia

1-8-2018

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Active substance: Meningococcal group A, C, W-135 and Y conjugate vaccine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5220 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2226/T/80

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open

Scientific guideline: Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open

The main aim of the guideline is to outline the information which should be included for the adjuvant in the marketing authorisation application (MAA) of an immunological veterinary medicinal product (IVMP). This guideline replaces the ‘Note for Guidance on the use of adjuvanted veterinary vaccines’. The guideline discusses the important aspects to consider for the adjuvant in an IVMP and provides guidance on the information on the adjuvant which should be included in Parts 2, 3 and 4 of the MAA. The d...

Europe - EMA - European Medicines Agency

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

9-2-2018

Suvaxyn Circo (Zoetis Belgium S.A.)

Suvaxyn Circo (Zoetis Belgium S.A.)

Suvaxyn Circo (Active substance: Porcine circovirus vaccine (inactivated, recombinant)) - New authorisation - Commission Decision (2018)861 of Fri, 09 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4242

Europe -DG Health and Food Safety