Hipracox Broilers Spray

Main information

  • Trade name:
  • Hipracox Broilers Spray
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Hipracox Broilers Spray
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Coccidia vaccine
  • Therapeutic area:
  • Chicken Broilers

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0276/001
  • Authorization date:
  • 24-10-2007
  • EU code:
  • UK/V/0276/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:August2012

AN:01472/2011

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NameoftheproductinUnitedKingdom:HIPRACOXBROILERSspray

AllotherCMS:HIPRACOX.

Suspensionandsolutionforsprayforchickens.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionperdose(0.007ml)ofHIPRACOXBROILERSspray:

1.Activesubstances:

-Each0.007mldoseofvaccinecontainsthefollowingnumbersofsporulated

oocystsderivedfromfiveprecociousattenuatedlinesofcoccidia:

Eimeriaacervulina,strain003.............300 –390*

Eimeriamaxima,strain013.................200 –260*

Eimeriamitis,strain006.......................300 –390*

Eimeriapraecox,strain007.................300 –390*

Eimeriatenella,strain004....................250 –325*

*Accordingtoinvitroproceduresofthemanufactureratthetimeofblendingand

atrelease.

2.Excipientsandadjuvants.

UNIFLOCK(0.02ml/dose)

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Slightlybrownishtowhiteturbidoralsuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Chicken(broilers).

4.2 Indicationsforuse,specifyingthetargetspecies

Foractiveimmunisationofbroilerchickstoreduceintestinalcolonisation,intestinal

lesionsandclinicalsignsofCoccidiosiscausedbyEimeriaacervulina,Eimeria

maxima,Eimeriamitis,EimeriapraecoxandEimeriatenella.

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AN:01472/2011

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Theonsetofimmunityis14dayspost-vaccinationandthedurationofprotectionis

maintainedatleastfor28dayspost-vaccination.

4.3 Contraindications

None.

4.4 Specialwarningsforeachtargetspecies

ThevaccinewillnotprotectspeciesotherthanchickensagainstCoccidiosisand

isonlyeffectiveagainsttheEimeriaspeciesindicated.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Chickensmustbestrictlyfloor-rearedonlitter.

Donotvaccinateunhealthyorstressedbirds.

Littershouldberemovedandfacilitiesandmaterialcleanedbetweenproduction

cyclestoreducefieldinfections.

Seesection6.2.(Incompatibilities).

UseonlythecolouringagentUNIFLOCK(colouringagent).

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washanddisinfecthandsandequipmentafteruse.

Cleantheaffectedareawithsoapandwaterinthecaseofaccidentalspillage

ontotheskin.Incaseofaccidentalingestion,seekmedicaladviceimmediately

andshowthepackageinsertorthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

Theuseofthesetypeofvaccinesmayoccasionallyresultinatemporary

reductionindailyliveweightgainwithoutanyconsequencesonthefinal

performances.

4.7Useduringpregnancy,lactationorlay

Donotuseinlayersandbreeders.

4.8Interactionwithothermedicinalproductsandotherformsof

interaction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenused

withanyotherveterinarymedicinalproduct.Adecisiontousethisvaccinebefore

orafteranyotherveterinarymedicinalproductthereforeneedstobedecidedona

casebycasebasis.

Noanticoccidialdrugsorotheragentshavinganticoccidialactivityviafeedor

watershouldbeusedforatleast3weeksfollowingvaccinationofthechickens.

Thecorrectreplicationofthevaccineoocystsandconsequently,thedevelopment

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ofasolidimmunitycouldbehindered.Additionally,theenhancementofprotection

producedbyoocystre-infectionswouldalsobelimited.

4.9 Amountstobeadministeredandadministrationroute

Administeronedoseofvaccine(whichcorrespondsto0.007mlofthe1,000and

5,000dosespresentations)toeach1-dayoldchick.Allbirdsshouldbegivena

singledose.

Themethodofadministrationisbycoarsespray.

Methodofadministration(coarsespray):

Beforestartingthepreparation,asuitablecleancontainerofenoughcapacityis

requiredtopreparetheVaccineSolution(VS)(aminimumvolumeof287mlor

1435mlofcapacityforeach1000or5000-dosevial,respectively).

TopreparetheVS,theColouringAgentSolution(CAS) shouldbepreparedfirst.

TopreparetheCASshakethevialofUNIFLOCK(colouringagent)vigorously.

Dilutethecontentsofthevialwithcleanroomtemperaturewater(260mlor1300

mlofwaterforeach1000or5000-dosevial,respectively).

OncetheCASisprepared,shakethevialofHIPRACOXBROILERSspray

vigorouslyanddilutethecontentsintotheCAStopreparetheVS(280mlor1,400

mlofCASforeach1000or5000-dosevial,respectively).

FillthevaccinereservoirofthesprayingdevicewithalltheVSprepared.

MaintaintheVSincontinuoushomogenisation.Thevaccineisadministeredvia

coarsespraytothechicks,byspraying28mloftheVSforeach100chicks.The

pressureofthesprayingdeviceshouldbeat3bars.Thesprayingdevicemust

provideadropletsizeof

100

m.

Inordertoimprovetheuniformityofthe vaccinationmaintainthechicksinsidethe

chickboxforatleast1hourinordertoletthemingestallthevaccinedroplets.

Afterthistime,placethechicksinthelitterandcontinuewithregularmanagement

practices.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

None

4.11Withdrawalperiod(s)

Zerodays.

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5. IMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Liveparasiticvaccines,coccidia

ATCvetcode:QI01AN01

TostimulateactiveimmunityagainstCoccidiosiscausedbyEimeriaacervulina,

Eimeriamaxima,Eimeriamitis,EimeriapraecoxandEimeriatenella.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

HIPRACOXBROILERSspray UNIFLOCK(colouringagent)

PhosphateBufferedSolution(PBS): PatentBlueV(E131)

-PotassiumChloride CochinealRedAPonceau4R(E124)

-DisodiumPhosphate12H

O Vanillin

-PotassiumDihydrogenPhosphate PhosphateBufferedSolution(PBS):

-SodiumChloride -PotassiumChloride

-DisodiumPhosphate12H

O

-PotassiumDihydrogenPhosphate

-SodiumChloride

6.2Incompatibilities

Donotmixwithanyotherveterinarymedicinalproductexceptdiluentsorother

componentsuppliedforusewiththeproduct.

6.3Shelflife

HIPRACOXBROILERSspray:

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:6months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:Usethevaccineimmediately

afteropeninganddiscardunusedvaccines.

Shelf-lifeafterdilutionaccordingtodirections:10hours.

UNIFLOCK(colouringagent):

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale::1year.

6.4.Specialprecautionsforstorage

HIPRACOXBROILERSspray:

Storeandtransportrefrigerated(+2 –+8ºC).Protectfromlight.Donotfreeze.

UNIFLOCK(colouringagent):

Storebelow25ºC.Donotfreeze.

Revised:August2012

AN:01472/2011

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6.5Natureandcompositionofimmediatepackaging

ThecontainersofHIPRACOXBROILERSsprayaremadeof10-mland50-ml

TypeI(1,000and5,000doses)colourlessglassflaskswithTypeIpolymeric

elastomerclosuresandaluminiumFlip-caps.

ThecontainersofUNIFLOCK(colouringagent)aremadeof20-mland100-ml

TypeII(1,000and5,000doses)colourledglassflaskswithTypeIpolymeric

elastomerclosuresandaluminiumcaps.

Salespresentation:

HIPRACOXBROILERSsprayandUNIFLOCK(colouringagent)arepacked

independently.Botharepackedwiththesamesalespresentation:

Cardboardboxwitha1,000dosesvial.

Cardboardboxwitha5,000dosesvial.

Cardboardboxwith10vialsof1,000doses.

Cardboardboxwith10vialsof5,000doses.

Cardboardboxwith5vialsof5,000doses.

Cardboardboxwith6vialsof5,000doses.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

HIPRACOXBROILERSspray:Disposeofwastematerialsbyboiling,incineration

orimmersioninanappropriatedisinfectantapprovedforusebythecompetent

authorities.

UNIFLOCK(colouringagent):Anyunusedproductorwastematerialsshouldbe

disposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

LABORATORIOSHIPRA,SA.

Avda.laSelva,135.

17170-AMER(Girona)Spain.

8.MARKETINGAUTHORISATIONNUMBER(S):

Vm17533/4008.

9.DATEOFFIRSTAUTHORISATION

23May2007

10.DATEOFREVISIONOFTHETEXT

August2012

Revised:August2012

AN:01472/2011

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PROHIBITIONOFSALE,SUPPLYAND/ORUSE.

Non-applicable