DICLAZURIL

Main information

  • Trade name:
  • DICLAZURIL
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DICLAZURIL
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • diclazuril
  • Therapeutic area:
  • Cattle Young, Sheep Young

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0190/001
  • Authorization date:
  • 24-07-2011
  • EU code:
  • FR/V/0190/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

[12480DICLAZURILFINALSPCRenewal]

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DiclazurilELANCO2.5mg/mlOralSuspensionforlambsandcalves

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Diclazuril 2.5mg

Excipients:

Methylparahydroxybenzoate(E218) 1.8mg

Propylparahydroxybenzoate(E216) 0.2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

White,oralsuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Ovine(lambs)andbovine(calves).

4.2 Indicationsforuse,specifyingthetargetspecies

Inlambs:

PreventionofcoccidiosiscausedbyEimeriacrandallisandEimeriaovinoidalis.

Incalves:

PreventionofcoccidiosiscausedbyEimeriabovisandEimeriazuernii.

Ifthereisnorecentandconfirmedhistoryofclinicalcoccidiosis,thepresenceofcoccidiain

theflockorherdshouldbeconfirmedbyfaecalsamplingpriortotreatment.

4.3 Contraindications

Donotuseincasesofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

Calves:incertaincases,onlyatransientreductionofoocystsheddingmaybeachieved.

Avoidunderdosing,whichmaybeduetounderestimationofbodyweight,misadministration

oftheproduct,orlackofcalibrationofthedosingdevice(ifany).

Suspectedclinicalcasesofresistancetoanticoccidialsshouldbefurtherinvestigatedusing

appropriatetests(e.g.FaecalEggCountReductionTest).Wheretheresultsofthetest(s)

stronglysuggestresistancetoaparticularanthelmintic,ananticoccidialbelongingtoanother

pharmacologicalclassandhavingadifferentmodeofactionshouldbeused.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

ThepreferredtimingoftreatmentisdirectedbytheknownepidemiologyofEimeriaspp.and

thepresenceofcoccidiaintheflockorherdshouldbeconfirmedbyfaecalsamplingpriorto

treatment,ifthereisnorecentandconfirmedhistoryofclinicalcoccidiosis.

Coccidiosisisanindicatorofinsufficienthygieneintheflock/pen.Itisrecommendedto

improvehygieneandtotreatalllambsintheflockandallcalvesinapen.

Frequentandrepeateduseofantiprotozoalsmayleadtothedevelopmentofresistanceinthe

targetparasite.

Toalterthecourseofanestablishedclinicalcoccidialinfection,inindividualanimalsalready

showingsignsofdiarrhoea,additionalsupportivetherapymayberequired.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteradministrationoftheproduct.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

Notapplicable.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

1mgdiclazurilperkgbodyweight(i.e.1mloftheoralsuspensionper2.5kgbodyweight),

inasingleoraladministration.

Shakewellbeforeuse.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossible.

Ifanimalsaretobetreatedcollectivelyratherthanindividually,theyshouldbegrouped

accordingtotheirbodyweightanddosedaccordingly,inordertoavoidunder-oroverdosing.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inlambs:nosignsofoverdosewerenotedafteradministrationof5timestherecommended

dose.

Incalves:nosignsofoverdosewerenotedafterasingleadministrationof5timesthe

recommendeddose.Incaseofrepeatedadministrationof3to5timesthedose,on3

consecutivedays,asofteningandacolourchange(darkbrown)ofthefaecescanbeobserved

insomecalves.Theseobservationsweretransientanddisappearedwithoutspecifictreatment.

4.11 Withdrawalperiod(s)

Meatandoffal:

Lambs:zerodays

Calves:zerodays

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiprotozoals,Triazines

ATCVetCode:QP51AJ03

5.1 Pharmacodynamicproperties

Diclazurilisananticoccidialofthebenzeneacetonitrilegroupandhasanticoccidialactivity

againstEimeriaspecies.Dependingonthecoccidiaspecies,diclazurilhasacoccidiocidal

effectontheasexualorsexualstagesofthedevelopmentcycleoftheparasite.Diclazuril

treatmentwillonlyhavelimitedeffectontheintestinallesionscausedbyparasiticstages

olderthan16days.Treatmentwithdiclazurilcausesinterruptionofthecoccidialcycleandof

excretionofoocystsforapproximately2weeks.Thisallowstheanimaltobridgetheperiod

ofdecreaseofmaternalimmunity(observedatapproximately4weeksofage).

5.2 Pharmacokineticparticulars

Theabsorptionofdiclazurilinlambsispoorafteradministrationoftheoralsuspension.

Maximumconcentrationsinplasmaarereachedabout24hoursafterdosing.Theabsorption

decreaseswiththeanimals’age.Theeliminationhalf-lifeisabout30hours.In-vitrostudies

onsheephepatocytesdemonstratedthatmetabolictransformationofdiclazurilislimited.This

wasequallyobservedinotheranimalspecies.Excretionoccursalmostcompletelyviathe

faeces.

Whendiclazurilisadministeredinoralsuspensiontocalves,itsabsorptionispoor.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Microcrystallinecelluloseandcarboxymethylcellulosesodium

Citricacidmonohydrate

Polysorbate20

Sodiumhydroxide

Purifiedwater

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelflifeafterfirstopeningtheimmediatepackaging:3months

6.4.Specialprecautionsforstorage

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Natureofthecontainer

Highdensitypolyethylenebottle

Highdensitypolyethyleneclosure

Highdensitypolyethylenenozzleclosure.

Commercialpack(s)

Boxwith200mlcontainerwithharnessandspoutedcap

Boxwith1Lcontainerwithharnessandspoutedcap

Boxwith2.5Lcontainerwithharnessandspoutedcap

Boxwith5Lcontainerwithharnessandspoutedcap

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

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8. MARKETINGAUTHORISATIONNUMBER(S)

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9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

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10 DATEOFREVISIONOFTHETEXT

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PROHIBITIONOFSALE,SUPPLYAND/ORUSE