POULVAC IB QX

Main information

  • Trade name:
  • POULVAC IB QX
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • POULVAC IB QX
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Avian infectious bronchitis virus
  • Therapeutic area:
  • Chicken

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0253/001
  • Authorization date:
  • 20-03-2013
  • EU code:
  • FR/V/0253/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

[Version8,10/2012]

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PoulvacIBQXlyophilisateforsuspensionforsprayforchickens

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onedosecontains:

Activesubstance:

LiveattenuatedAvianInfectiousBronchitisVirus,strainL114810 3.0 –10 5.0 EID

.

*EID 50 =50%EmbryoInfectiveDose.

Excipient:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Lyophilisateforsuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Chickens.

4.2 Indicationsforuse,specifyingthetargetspecies

ForactiveimmunisationofchickensinordertoreducerespiratorysignsofInfectiousBronchitiscaused

byQX-likevariantsofInfectiousBronchitisvirus.

Onsetofimmunity:3weeksaftervaccination.

Durationofimmunity:63daysaftervaccination.

4.3 Contraindications

Donotuseduringlay.

Donotvaccinatefuturelayers/breedersbefore1weekofage.

4.4 Specialwarnings

Thevaccinevirusiscapableofspreadingtoincontactbirdsforaminimumof14daysafter

vaccinationandappropriatecareshouldbetakentoseparatevaccinatedfromnon-vaccinated

chickens.Precautionarymeasuresshouldbetakentopreventspreadingtowildlife.

Cleaninganddisinfectionofthepremisesaftervaccinationisadvisable.

ThisvaccineshouldonlybeusedafterithasbeenestablishedthattheQX-likeIBVvariantstrainis

epidemiologicallyrelevant.

ItisimportanttoavoidintroductionoftheIBQXvaccinevirusintopremisesinwhichthewildtype

strainisnotpresent.TheIBQXvaccineshouldonlybeappliedinhatcheriesifadequatecontrolsare

inplacetoavoidthespreadofthevaccinevirustobirdsthatwillbetransportedtonon-IBQXexposed

flocks.

ThevaccinehasbeendemonstratedtoprovideprotectionagainstQX-likevariant.Theprotection

againstothercirculatingIBstrainshasnotbeeninvestigated.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Vaccinateonlyhealthyanimals.

Allchickensonthesiteshouldbevaccinatedatthesametime.

Asthereisasmallrangebetweentheefficaciousvaccinedoseandanon-efficaciousdose,takecare

toadministertherightdose.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Careshouldbetakenwhenreconstitutingandadministeringthevaccine.Wearasuitablerespiratory

maskandeyeprotectiontoavoiddirectcontactwiththeaerosolizedvaccine.Washanddisinfect

handsafteruse.

Otherprecautions

Notapplicable.

4.6 Adversereactions(frequencyandseriousness)

Noundesirableeffecthasbeenobservedaftervaccination.

4.7 Useduringpregnancy,lactationorlay

Noinformationisavailableonthesafetyofthevaccineduringlay.

Donotuseinbirdsinlayand/orwithin4weeksbeforetheonsetofthelayingperiod.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafteranyotherveterinary

medicinalproductthereforeneedstobemadeonacasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Vaccinationschedule

Broilers:onedoseofvaccinefrom1dayofagebysprayvaccination.

Futurelayersorbreeders:onedoseofvaccinefrom7daysofagebysprayvaccination.

Administration

PoulvacIBQXcanbeusedinmosttypesofsprayequipment.Theequipmentshouldprovidecoarse

spray(dropletsbetween80to160μm).Thedistancefromthesprayingheadtothebirdmustbe

approximately50cm.Use0.15to0.5litresofwaterper1000birdsdependingofthetypeofspray

equipmenttobeused.

Removethealuminiumsealfromthevaccinevial.Todissolvethevaccinepellet,therubberstopper

shouldberemovedwhilstthevialisimmersedinaplasticmeasuringjugcontaining1litreofcleancool

water.Halffillthevialwithwater,replacethestopperandshaketodissolveanyremainingvaccine.

Thevaccineconcentrateshouldthenbeaddedtothewaterinthespraytankandthoroughlymixed.

Administeratarateofonedoseofpreparedvaccineperbird.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Renallesions(paleness,microscopiclesions)canbeobservedafteradministrationofa10fold

overdose.

4.11Withdrawalperiod

Zerodays.

5. IMMUNOLOGICALPROPERTIES

ActiveimmunisationagainstavianInfectiousBronchitisvirusvariantstrainIBQX-likewhichcauses

infectiousbronchitisinchickens

ATCvetcode:QI01AD07

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

D-mannitol

Gelatine

Inositol

Peptone

Waterforinjection

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelf-lifeafterreconstitution:2hours.

6.4.Specialprecautionsforstorage

Storeandtransportrefrigerated(2

C–8

C)

Donotfreeze.

Protectfromlight

6.5 Natureandcompositionofimmediatepackaging

Glassbottles.

Chlorobutylrubberstopperssealedwithaluminiumcrimpcaps.

PackSizes:

Boxof10x2000doses

Boxof10x5000doses

Boxof10x10000doses.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriatedisinfectantapprovedfor

usebythecompetentauthorities.

7. MARKETINGAUTHORISATIONHOLDER

(MAHolder)

(Addresstobedefinedforeachcountrywherethelicencewouldbegranted)

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Tobedefined

10 DATEOFREVISIONOFTHETEXT

Tobedefined

30-11-2018

Reporting Avian Influenza surveillance

Reporting Avian Influenza surveillance

Published on: Thu, 29 Nov 2018 Avian influenza viruses infect domestic poultry and wild birds as well as humans. In poultry, depending on whether these viruses are of high pathogenicity (HPAI) or low pathogenicity (LPAI), the infection can cause different clinical signs, with HPAI causing high mortality in poultry flocks. In order to ensure early detection of avian influenza viruses, surveillance in poultry and wild birds is considered essential. In 2010, the European Commission provided some guidelines...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

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