Z-Itch

Main information

  • Trade name:
  • Z-Itch 40mg/ ml Pour-on Solution
  • Pharmaceutical form:
  • Pour-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Z-Itch 40mg/ml Pour-on Solution
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • permethrin
  • Therapeutic area:
  • Horses Non Food, Horses Other

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0477/001
  • Authorization date:
  • 20-03-2013
  • EU code:
  • UK/V/0477/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:August2013

AN:00620/2012

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Z-Itch

40mg/mlPour-onSolution

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Permethrin(80:20)technical 40.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Pour-onsolution.

Aclear,colourlesstopaleyellow,non-aqueoussolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Horsesanddonkeys.

4.2 Indicationsforuse,specifyingthetargetspecies

ForthecontrolofthebitinginsectCulicoidesspp.Thisproductmaybeusedasanaidin

thecontrolofsweetitch

4.3 Contraindications

Donotadministertohorsesanddonkeysintendedforhumanconsumption.

Donottreatthesaddlearea.

4.4 Specialwarnings

Sweetitchisbelievedtobecausedbyhypersensitivitytothebitesofflyinginsectse.g.

Culicoidesspecies.Inadditiontotreatment,othermeasuresshouldbetakentoreduce

exposuretosuchinsectswherepracticable.Itmaybeappropriateforownerstoseek

veterinaryadviceonmanagementofhorseswithsweetitch.Itisalsorecommendedthat

ownersseekveterinaryadviceinseverecasesofsweetitchandincasesofsweetitch

whichdonotrespondtotreatment.

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Forexternaluseonly.

Theproductmustnotbeappliedforwardoftheears.

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Takecaretoavoideyecontact.

Incaseofaccidentalsplashingintothehorse'seye,theaffectedeyeshouldbewashed

thoroughlyandimmediatelywithcopiousquantitiesofcleanwaterandveterinaryattention

sought.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Wearprotectiveclothing,bootsandchemicallyresistantglovessuchasrubber,PVCor

nitrilewhenapplyingtheproduct.Washsplashesfromskinandeyesimmediately.

Whenusingtheproductdonoteat,drinkorsmoke.

Washhandsandexposedskinbeforeeating,drinkingorsmokingandafterwork.

Useinawellventilatedarea.

Keepawayfromfood,drinkandanimalfeedingstuffs.

4.6Adversereactions(frequencyandseriousness)

Afewhorses,particularlythoseofthefine-skinnedArabtype,mayreactadverselyto

treatmentwiththeproduct.Insuchindividualsasmallpatchtestatthebaseoftheneckis

recommended.Ifadversereactionsshouldoccur,treatmentshouldbestopped

immediately.Anyresultingskinirritationisshortlived.

Procedureforpatchtesting

Usingprotectiveglovesapplyasmallquantityoftheproduct(about1ml)toanidentifiable

areaatthebaseoftheanimal’sneckandrubontotheskinwithaswab.Wraptheused

swabintheglovesanddisposeofsafely.At24and48hoursafterapplication,examine

theareatowhichtheproductwasappliedandobservetheskinforsignsofreaction

(redness,swelling,flakingorexudation).Ifareactionoccurs,donotusetheproducton

theanimal.

4.7Useduringpregnancy,lactationorlay

Nospecialprecautionsrequired.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Careshouldbetakenwhenapplyingtheproductasitmayhaveanadverseeffecton

certainplastics.

4.9 Amountstobeadministeredandadministrationroute

Horsesanddonkeys:4mg/kgbodyweight,equivalentto1.0mlper10kgbodyweightto

amaximumof40ml.

Dosageguidelines

Bodyweight(kg) 100 200 250 300 >400

Dosevolume(ml) 10 20 25 30 40

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Applythemeasureddoseinapproximatelyequalproportionstothemaneandrump

avoidingthesaddlearea.Treatmentshouldbestartedatthebeginningofthesweetitch

seasonandrepeatedasnecessary-treatmentonceweeklyshouldbesufficientformost

horses.

Ifhorsesanddonkeysaretobegroomed,applytheproductaftergrooming.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Toxicsignsinmammalsaretremors,hyperexcitability,salivation,choreoathetosisand

paralysis.Thesignsdisappearrapidlyandtheanimalsrecover,generallywithinaweek.

Thereisnospecificantidotebutsymptomatictherapycanbegivenifconsidered

necessary.

4.11Withdrawalperiod(s)

Nottobeusedinhorsesintendedforhumanconsumption.

Treatedhorsesmayneverbeslaughteredforhumanconsumption.

Thehorsemusthavebeendeclaredasnotintendedforhumanconsumptionunderthe

nationalhorsepassportlegislation.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Ectoparasiticide.

ATCvetcode:QP53AC04.

5.1 Pharmacodynamicproperties

Permethrinisaneurotoxinaffectingtheaxonsintheinsectperipheralandcentralnervous

systembyinteractionwithsodiumchannels.

5.2 Pharmacokineticparticulars

Theproductisindicatedforcutaneousadministration.Followingtopicalapplicationtothe

animal,thesolutionisdistributedovertheskin.

Syntheticpyrethroidsaregenerallymetabolisedinmammalsthroughesterhydrolysis,

oxidationandconjugationandthereisnotendencyfortissueaccumulation.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Butyldioxitol.

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

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6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintightlyclosedoriginalcontainerinadryplace.

Protectfromlight.

6.5Natureandcompositionofimmediatepackaging

Containersize: 250ml.

Container

material: Natural,highdensitypolyethylene.

Closure: White,polypropylenescrewfitcapwithinductionseal.

Dosingdevice: Integralgraduateddispensingchamber.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Dangeroustofishandotheraquaticlife.Donotcontaminateponds,waterwaysorditches

withtheproductorusedcontainer.

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

FlorisVeterinaireProduktenBV

Kempenlandstraat33/35

5262GKVught

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm36057/4000

9. DATEOFFIRSTAUTHORISATION

27January2011

10. DATEOFREVISIONOFTHETEXT

August2013

Approved: 21/08/2013