Hipracox Broilers dw

Main information

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

Documents

Localization

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

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0275/001
  • Authorization date:
  • 24-10-2007
  • EU code:
  • UK/V/0275/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Revised:August2012

AN:01471/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NameoftheproductinUnitedKingdom:HIPRACOXBROILERSdw

NameoftheproductinSpain:HIPRACOXaguadebebida.

NameoftheproductinPortugal:HIPRACOXab.

NameoftheproductinFrance:HIPRACOXeb.

NameoftheproductinSweden:HIPRACOXad.

AllotherCMS:HIPRACOXdw.

Oralsuspensionforuseindrinkingwaterforchickens.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionperdose(0.007ml):

-Each0.007mldoseofvaccinecontainsthefollowingnumbersof

sporulatedoocystsderivedfromfiveprecociousattenuatedlinesofcoccidia:

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

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

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

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

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

*Accordingtoinvitroproceduresofthemanufactureratthetimeofblending

andatrelease.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Slightlybrownishtowhiteturbidoralsuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Chicken(broilers).

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AN:01471/2011

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4.2 Indicationsforuse,specifyingthetargetspecies

Foractiveimmunisationofbroilerchickstoreduceintestinalcolonisation,

intestinallesionsandclinicalsignsofCoccidiosiscausedbyEimeriaacervulina,

Eimeriamaxima,Eimeriamitis,EimeriapraecoxandEimeriatenella.

Theonsetofimmunityis14dayspost-vaccinationandthedurationof

protectionismaintainedatleastfor28dayspost-vaccination.

4.3 Contraindications

None.

4.4 Specialwarningsforeachtargetspecies

ThevaccinewillnotprotectspeciesotherthanchickensagainstCoccidiosis

andisonlyeffectiveagainsttheEimeriaspeciesindicated.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Chickensmustbestrictlyfloor-rearedonlitter.

Donotvaccinateunhealthyorstressedbirds.

Thevaccinemustonlybeadministeredwithhand-filledsupplementarydrinkers.

Donotuseanyothertypeofwaterdistributionsystemforvaccinationsuchas

belldrinkers,nippledrinkersandautomaticcupdrinkers.

Littershouldberemovedandfacilitiesandmaterialcleanedbetweenproduction

cyclestoreducefieldinfections.

Seesection6.2.(Incompatibilities).

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washanddisinfecthandsandequipmentafteruse.

Cleantheaffectedareawithsoapandwaterinthecaseofaccidentalspillage

ontotheskin.Incaseofaccidentalingestion,seekmedicaladvice

immediatelyandshowthepackageinsertorthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

Theuseofthesetypeofvaccinesmayoccasionallyresultinatemporary

reductionindailyliveweightgainwithoutanyconsequencesonthefinal

performances.

4.7Useduringpregnancy,lactationorlay

Donotuseinlayersandbreeders.

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AN:01471/2011

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4.8Interactionwithothermedicinalproductsandotherformsof

interaction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhen

usedwithanyotherveterinarymedicinalproduct.Adecisiontousethis

vaccinebeforeorafteranyotherveterinarymedicinalproducttherefore

needstobedecidedonacasebycasebasis.

Noanticoccidialdrugsorotheragentshavinganticoccidialactivityviafeedor

watershouldbeusedforatleast3weeksfollowingvaccinationofthe

chickens.Thecorrectreplicationofthevaccineoocystsandconsequently,

thedevelopmentofasolidimmunitycouldbehindered.Additionally,the

enhancementofprotectionproducedbyoocystre-infectionswouldalsobe

limited.

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AN:01471/2011

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4.9 Amountstobeadministeredandadministrationroute

Administeronedoseofvaccine(whichcorrespondsto0.007mlofthe1,000

and5,000dosespresentations)toeach1-dayoldchick.Allbirdsshouldbe

givenasingledose.

Themethodofadministrationisbyoralrouteinthedrinkingwater.

Methodofadministration(drinkingwater):

Fortheadministrationofthevaccine,hand-filledsupplementarydrinkersmust

beused(seesection4.5.).

Watershouldbewithheldfor2-4hourspriortovaccination(thistimeincludes

thetransportationfromthehatcherytothefarm).

Provideadequatenumberofmini-drinkersordrinkingspacesothatallchicks

haveaccesstothevaccinalwaterandthus,canreceivethecorrectdoseof

thevaccine.

Distributehomogeneouslythemini-drinkersintheareawherechicksare

housedatarateof1mini-drinkerforevery100-150birds.Preferablydistribute

thedrinkersinalineunderornexttotheareawherethedefinitivedrinkerswill

beplaced.

Makesurethatmini-drinkersarethoroughlycleanedandnotplacedunderthe

brooders.

Oncethemini-drinkersareplaced,shakethevialofvaccinevigorously5to10

timesbeforeopening.

Thoroughlymixthecontentofthevialwiththeappropriateamountofclean

androomtemperaturewater(10litresor50litresofwaterfor1,000dosesand

5,000doses,respectively).Avoidtheuseofverycoldorveryhotwater.

Stirgentlyuntilthevaccineisfullyhomogenizedinthewater.

Filleachmini-drinkerwith1to1.5litresdependingontherateofanimalsper

drinker(1litrefor100birdsperdrinkeror1.5litresfor150birdspermini-

drinker).

Itisimportanttoensurethattoomanybirdsdonotgatheraroundonemini-

drinker.Ifso,walkthroughthebirdssoftlytoincreasethechanceofweaker

birdstoobtainaccesstothemini-drinkersandthus,tothevaccinalwater.

Removethemini-drinkersoncethewaterhasbeenfullyconsumedand

routineadministrationofwatermaycontinue.

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4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

None

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Liveparasiticvaccines,coccidia

ATCvetcode:QI01AN01

TostimulateactiveimmunityagainstCoccidiosiscausedbyEimeria

acervulina,Eimeriamaxima,Eimeriamitis,EimeriapraecoxandEimeria

tenella.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PotassiumChloride

DisodiumPhosphate12H2O

PotassiumDihydrogenPhosphate

SodiumChloride

6.2Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:6months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:Usethevaccine

immediatelyafteropeninganddiscardunusedvaccines.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:10hours.

6.4.Specialprecautionsforstorage

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

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6.5Natureandcompositionofimmediatepackaging

Thecontainersaremadeof10-mland50-mlTypeI(1,000and5,000doses)

colourlessglassflaskswithTypeIpolymericelastomerclosuresand

aluminiumFlip-caps.

Salespresentation:

Cardboardboxwitha1,000dosesvial.

Cardboardboxwitha5,000dosesvial.

Cardboardboxwith10vialsof1,000doses.

Cardboardboxwith10vialsof5,000doses.

Cardboardboxwith5vialsof5,000doses.

Cardboardboxwith6vialsof5,000doses.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinary

medicinalproductorwastematerialsderivedfromtheuseofsuch

products

Disposeofwastematerialbyboiling,incinerationorimmersioninanappropriate

disinfectantapprovedforusebythecompetentauthorities.

7. MARKETINGAUTHORISATIONHOLDER

LABORATORIOSHIPRA,SA.

Avda.laSelva,135.

17170-AMER(Girona)Spain.

8.MARKETINGAUTHORISATIONNUMBER

Vm17533/4007

9.DATEOFFIRSTAUTHORISATION

23May2007

10.DATEOFREVISIONOFTHETEXT

August2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE.

Non-applicable