Hipracox Broilers

Main information

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

Documents

Localization

  • Available in:
  • Hipracox Broilers
    Greece
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0260/001
  • Authorization date:
  • 05-11-2011
  • EU code:
  • UK/V/0260/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:August2011

AN:01345/2010

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

HIPRACOXBROILERSOralsuspensionforchickens.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionperdose(0.007ml)ofHIPRACOXBROILERS:

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*

*Accordingtoinvitroproceduresofthemanufactureratthetimeofblending

andatrelease.

2.Excipientsandadjuvants:

Diluentforcoarsesprayonly: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.

Theonsetofimmunityis14dayspost-vaccinationandthedurationofprotection

ismaintainedatleastfor42dayspost-vaccination.

4.3 Contraindications

None.

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4.4 Specialwarningsforeachtargetspecies

ThevaccinewillnotprotectspeciesotherthanchickensagainstCoccidiosis

andisonlyeffectiveagainsttheEimeriaspeciesindicated.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Chickensmustbestrictlyfloor-rearedonlitter.

Donotvaccinateunhealthyorstressedbirds.

Forthedrinkingwateradministration,thevaccinemustonlybeadministeredwith

hand-filledsupplementarydrinkers.Donotuseanyothertypeofwaterdistribution

systemforvaccinationsuchasbelldrinkers,nippledrinkersandautomaticcup

drinkers.

Littershouldberemovedandfacilitiesandmaterialcleanedbetweenproduction

cyclestoreducefieldinfections.

Seesection6.2.(Incompatibilities).

Forcoarsesprayadministration,useonlythecolouringagentUNIFLOCK.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washanddisinfecthandsandequipmentafteruse.

Cleantheaffectedareawithsoapandwaterinthecaseofaccidentalspillage

ontotheskin.Seekmedicaladviceimmediatelyandshowthepackageinsertor

thelabeltothephysicianifaccidentallyingested.

4.6 Adversereactions(frequencyandseriousness)

None.

4.7 Useduringpregnancy,lactationorlay

Donotuseinlayersandbreeders.

4.8 Interactionwithothermedicinalproductsandotherformsof

interaction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenused

withanyotherveterinarymedicinalproduct.Adecisiontousethisvaccine

beforeorafteranyotherveterinarymedicinalproductthereforeneedstobe

decidedonacasebycasebasis.

Noanticoccidialdrugsorotheragentshavinganticoccidialactivityviafeedor

watershouldbeusedforatleast3weeksfollowingvaccinationofthechickens.

Thecorrectreplicationofthevaccineoocystsandconsequently,the

developmentofasolidimmunitycouldbehindered.Additionally,the

enhancementofprotectionproducedbyoocystre-infectionswouldalsobe

limited.

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4.9 Amountstobeadministeredandadministrationroute

Administeronedoseofvaccine(whichcorrespondsto0.007mlofthe1,000

and5,000dosespresentations)toeach1-dayoldchick.Allbirdsshouldbe

givenasingledose.

Themethodofadministrationisbyoralrouteinthedrinkingwaterorcoarse

spray.

Methodofadministration(drinkingwater):

Fortheadministrationofthevaccine,hand-filledsupplementarydrinkersmustbe

used(seesection4.5.).

Watershouldbewithheldfor2-4hourspriortovaccination(thistimeincludesthe

transportationfromthehatcherytothefarm).

Provideadequatenumberofmini-drinkersordrinkingspacesothatallchicks

haveaccesstothevaccinalwaterandthus,canreceivethecorrectdoseofthe

vaccine.

Distributehomogeneouslythemini-drinkersintheareawherechicksarehoused

atarateof1mini-drinkerforevery100-150birds.Preferablydistributethe

drinkersinalineunderornexttotheareawherethedefinitivedrinkerswillbe

placed.

Makesurethatmini-drinkersarethoroughlycleanedandnotplacedunderthe

brooders.

Oncethemini-drinkersareplaced,shakethevialofvaccinevigorously5to10

timesbeforeopening.

Thoroughlymixthecontentofthevialwiththeappropriateamountofcleanand

roomtemperaturewater(10litresor50litresofwaterfor1,000dosesand5,000

doses,respectively).Avoidtheuseofverycoldorveryhotwater.

Stirgentlyuntilthevaccineisfullyhomogenizedinthewater.

Filleachmini-drinkerwith1to1.5litresdependingontherateofanimalsper

drinker(1litrefor100birdsperdrinkeror1.5litresfor150birdspermini-drinker).

Itisimportanttoensurethattoomanybirdsdonotgatheraroundonemini-

drinker.Ifso,walkthroughthebirdssoftlytoincreasethechanceofweakerbirds

toobtainaccesstothemini-drinkersandthus,tothevaccinalwater.

Removethemini-drinkersoncethewaterhasbeenfullyconsumedandroutine

administrationofwatermaycontinue.

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Methodofadministration(coarsespray):

Beforestartingthepreparation,asuitablecleancontainerofenoughcapacityis

requiredtopreparetheVaccineSolution(VS)(aminimumvolumeof287mlor

1435mlofcapacityforeach1000or5000-dosevial,respectively).

TopreparetheVS,theColouringAgentSolution(CAS) shouldbepreparedfirst.

TopreparetheCASshakethevialofColouringAgent(UNIFLOCK)vigorously.

Dilutethecontentsofthevialwithcleanroomtemperaturewater(260mlor1300

mlofwaterforeach1000or5000-dosevial,respectively).

OncetheCASisprepared,shakethevialofHIPRACOXBROILERSvigorously

anddilutethecontentsintotheCAStopreparetheVS(280mlor1,400mlof

CASforeach1000or5000-dosevial,respectively).

FillthevaccinereservoirofthesprayingdevicewithalltheVSprepared.

MaintaintheVSincontinuoushomogenisation.Thevaccineisadministeredvia

coarsespraytothechicks,byspraying28mloftheVSforeach100chicks.The

pressureofthesprayingdeviceshouldbeat3bars.Thesprayingdevicemust

provideadropletsizeof

100

m.

Inordertoimprovetheuniformityofthe vaccinationmaintainthechicksinside

thechickboxforatleast1hourinordertoletthemingestallthevaccine

droplets.

Afterthistime,placethechicksinthelitterandcontinuewithregular

managementpractices.

4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

None.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Liveparasiticvaccines,coccidia

ATCvetcode:QI01AN01

TostimulateactiveimmunityagainstCoccidiosiscausedbyEimeriaacervulina,

Eimeriamaxima,Eimeriamitis,EimeriapraecoxandEimeriatenella.

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6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

HIPRACOXBROILERS UNIFLOCK

PhosphateBufferedSolution(PBS): PatentBlueV(E131)

-PotassiumChloride CochinealRedAPonceau4R(E124)

-DisodiumPhosphate12H

O Vanillin

-PotassiumDihydrogenPhosphate PhosphateBufferedSolution(PBS):

-SodiumChloride -PotassiumChloride

-DisodiumPhosphate12H

O

-PotassiumDihydrogenPhosphate

-SodiumChloride

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproductexceptdiluentsorother

componentsuppliedforusewiththeproduct.

6.3 Shelflife

HIPRACOXBROILERS:

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:6months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:Usethevaccine

immediatelyafteropeninganddiscardunusedvaccines.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:itshouldnot

exceed10hours.

UNIFLOCK:

Shelf-lifeoftheveterinarymedicinalproductaspackageforsale:12months.

6.4. Specialprecautionsforstorage

HIPRACOXBROILERS:

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

UNIFLOCK:

Storebelow25ºC.Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

ThecontainersofHIPRACOXBROILERSaremadeof10-mland50-mlTypeI

(1,000and5,000doses)colourlessglassflaskswithTypeIpolymeric

elastomerclosuresandaluminiumFlip-caps.

ThecontainersofUNIFLOCKaremadeof20-mland100-mlTypeII(1,000and

5,000doses)colouredglassflaskswithTypeIpolymericelastomerclosures

andaluminiumcaps.

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Salespresentation:

HIPRACOXBROILERSandUNIFLOCKarepackedindependently.Bothare

packedwiththesamesalespresentation:

Cardboardboxwitha1,000dosesvial.

Cardboardboxwitha5,000dosesvial.

Cardboardboxwith10vialsof1,000doses.

Cardboardboxwith10vialsof5,000doses.

Cardboardboxwith5vialsof5,000doses.

Cardboardboxwith6vialsof5,000doses.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

HIPRACOXBROILERS:Disposeofwastematerialsbyboiling,incinerationor

immersioninanappropriatedisinfectantapprovedforusebythecompetent

authorities.

UNIFLOCK:Anyunusedproductorwastematerialsshouldbedisposedofin

accordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

LABORATORIOSHIPRA,SA.

Avda.laSelva,135.

17170-AMER(Girona)Spain.

8. MARKETINGAUTHORISATIONNUMBER

Vm17533/4004

9. DATEOFFIRSTAUTHORISATION

01June2006

10 DATEOFREVISIONOFTHETEXT

August2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.