CliKZin 1.25% (w/v) Pour-on Suspension for Sheep

Main information

  • Trade name:
  • CliKZin 1.25% (w/v) Pour-on Suspension for Sheep
  • Pharmaceutical form:
  • Pour-on suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CliKZin 1.25% (w/v) Pour-on Suspension for Sheep
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Dicyclanil
  • Therapeutic area:
  • Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0346/001
  • Authorization date:
  • 19-08-2011
  • EU code:
  • UK/V/0346/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:August2011

AN:00355/2011

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CLiKZiN1.25%(w/v)Pour-OnSuspensionforSheep

CLiKZiN12.5mg/mLPour-OnSuspensionforSheep(ES)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Dicyclanil(INN),12.5mg/ml(1.25%w/v)

Excipient(s):

Colouringmatters:Quinolineyellow(E104) 0.005%(w/v)

PatentblueV(E131) 0.005%(w/v)

Preservatives:Methylparahydroxybenzoate(E218) 0.15%(w/v)

Propylparahydroxybenzoate(E216) 0.30%(w/v)

Butylatedhydroxytoluene(E321) 0.05%(w/v)

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Pour-onsuspension

4. CLINICALPARTICULARS

4.1 Targetspecies

Sheep

4.2 Indicationsforuse,specifyingthetargetspecies

PreventionofblowflystrikeonsheepduetoLuciliasericata.

4.3 Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceoranyofthe

excipients.

4.4 Specialwarnings

Theproductisbestappliedbeforeananticipatedblowflychallenge,orwhena

blowflychallengeisidentifiedonorinthevicinityofthefarm.Establishedstrikes

mayrequireaseparatetreatmentwithaknockdowninsecticide.

Itisrecommendedthatanimalswithdirtyback-endsaredaggedorcrutchedprior

toapplication.Ifdaggingorcrutchingisundertakenintheweeksfollowing

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application,theseanimalsshouldbere-treated,otherwiseprotectioncouldbe

lost.

Donotapplyduringheavyrainfall,orwhensuchconditionsareexpected.The

resultingwashoutmayreducetheprotectionperiod.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Notapplicable.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

OperatorsshouldwearsyntheticrubberglovesandPVCtrousers

whenapplyingtheproduct.

Incaseofskincontactremovecontaminatedclothingand

thoroughlywashtheaffectedpartsofthebodywithsoapand

water.

Incaseofeyecontact,washimmediatelywithcleanwater.

Alwayswashhandsandexposedskinwithsoapandwaterafter

work.

Donoteat,drinkorsmokewhilstusingtheproduct.

Itisgoodagriculturalpracticetominimisehandlingofsheepafter

treatment.Ifyouneedtohandlesheepwithin2monthsafter

treatment,wearsyntheticrubberglovesandlongtrousersor

coveralls.Ifsheeparewetwearwaterprooftrousers.

iii. Otherprecautions

Treatedsheepmustbekeptawayfromwatercoursesforatleast

onehouraftertreatment.Thereisaseriousrisktoaquaticlifeif

thisadviceisnotfollowed.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyorlactation.Useonlyaccordinglytothebenefit/riskassessmentbythe

responsibleveterinarian.Laboratorystudiesinratsandrabbitshavenotshown

anyevidenceofteratogenic,foetotoxicormaternotoxiceffects.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

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4.9 Amountstobeadministeredandadministrationroute

Forexternaluseonly.

Theveterinarymedicinalproductisappliedaccordingtothefollowing

recommendations:

Bodyweight

(kg) Dosevolume

(ml)

10-20 20

21-30 24

31-50 30

>50 36

(Guidedosevolumescorrespondto0.7 –2ml(7.5–25mgdicyclanil)perkg

bodyweight.)

Recommendedfortreatmentinsheep3weekspostshearing.Shakethe

containerwellbeforeuse.

Theveterinarymedicinalproductmustbeappliedwithamanualorautomatic

dosinggun,fittedwithaspraynozzle,whichguaranteesthecorrectspreadingof

theproductonthefleece.Bestresultswillbeachievedbyholdingthegun

approximately45cmfromthesheepduringapplication.Applyasafanspray

alongthespineoftheanimalinbandsatleast10cmwidefromthemiddleofthe

shouldersandinanarcaroundthecrutchandtail.Halfthedoseshouldbe

appliedalongthespinewiththeremainderoverthetailandcrutcharea.The

veterinarymedicinalproductshouldbeadministeredbeforeoratthestartof

predictedflyactivitybutisalsosuitableforuseduringtheflyseason.

Theveterinarymedicinalproductwillprotectagainstflystrikefor8weeks.Itis

goodagriculturalpracticetocheckanimalsregularlyforflystrike.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Anoverdoseofuptoatleast20timestherecommendeddosedoesnotlead

toanysignsoflocalorsystemicintolerance.Noantidoteisknown.

4.11Withdrawalperiod(s)

Meatandoffal:7days

Donotuseonsheepproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Otherectoparasiticidesfortopicaluse.

ATCvetcode:QP53AX24.

5.1 Pharmacodynamicproperties

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DicyclanilpreventsthemoultfromthefirsttothesecondlarvalinstarofLucilia

spp.Itislesseffectiveagainstlaterlarvalstagesanddoesnothaveany

adulticideaction.Themodeofactionofdicyclanilisbelievedtobesimilartothat

ofthetriazinecompounds.

5.2 Pharmacokineticparticulars

Instudieswithamoreconcentrated5%(w/v)formulation,after7dayspost

dosing,approximately5%ofthedosewasabsorbedandeliminatedinurineand

faeces.Peakbloodlevelswereobservedbetween12and48hpostdose,

accountingfor<0.025mgdicyclanilequivalents/kg.

Inexperimentalmetabolismstudies,absorbedradioactivitywaswidely

distributedthroughoutthebody.Longesthalfliveswerefoundinliverandkidney

being13and10daysrespectively.Inmuscle,fatandwool,unchangeddicyclanil

wasfoundtobethemajorresidue,whereasinliverandkidneythe

descyclopropyldicyclanilwasfoundtobethemajorresiduetogetherwith

unchangeddicyclanil.

Infieldresiduedepletionstudiesonsheepwiththeveterinarymedicinalproduct,

residuelevelsatday7wereverylow(atmaximum31.9and30.7µg/kginliver

andkidney,respectively,andnoquantifiableresiduesfoundinmuscleorfat),

indicatingminimalsystemicabsorption.

5.3Environmentalproperties

Theuseoftheveterinarymedicinalproducthasharmfuleffectsondungfliesand

beetles.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Quinolineyellow(E104)

PatentblueV(E131)

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Butylatedhydroxytoluene(E321)

Polysorbate20

Acrylicacidcopolymer

Disodiumedetate

Distilledmonoglycerides

Triglycerides,medium-chain

Propyleneglycol

Sodiumhydroxide

Purifiedwater

6.2 Incompatibilities

Notapplicable.

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6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackedforsale:3years.

Shelf-lifeafterfirstopeningoftheimmediatepackaging:1year

6.4Specialprecautionsforstorage

Protectfromdirectsunlight.

Protectfromfrost.

Storeintightlyclosedoriginalcontainers,awayfromfood,drinkandanimal

feedstuffs.

6.5 Natureandcompositionofimmediatepackaging

Thepackiscomposedofpigmentedwhiteopaquepolyethylenebackpack

containerwithbluepolypropylenescrewcap,containing0.8,2.2or5litresof

finishedproduct.Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Harmfultoaquaticinvertebrates.

Donotcontaminatepondsorotherwaterwayswithproductoremptycontainers.

7. MARKETINGAUTHORISATIONHOLDER

NovartisAnimalHealthUKLtd

FrimleyBusinessPark

Frimley

Camberley

Surrey

GU167SR

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 12501/4171

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Date:September2010

10. DATEOFREVISIONOFTHETEXT

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Date:August2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.