Ectofly 1.25% w/v Pour-on Solution for Sheep

Main information

  • Trade name:
  • Ectofly 1.25% w/v Pour-on Solution for Sheep
  • Pharmaceutical form:
  • Pour-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ectofly 1.25% w/v Pour-on Solution for Sheep
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cypermethrin
  • Therapeutic area:
  • Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0426/001
  • Authorization date:
  • 22-02-2012
  • EU code:
  • UK/V/0426/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:June2012

AN:00524/2011

SummaryofProductCharacteristics

1. NameofVeterinaryMedicinalProduct

Ectofly12.5mg/mlPour-OnSolutionforSheep

2. QualitativeandQuantitativeComposition

Eachmlcontains

ActiveSubstance

CypermethrinHigh:Cis(80:20) 12.5mg

Excipients

GreenSDye(E142) 0.2mg

Forthefulllistofexcipients,seesection6.1.

3. PharmaceuticalForm

Pour-OnSolution.

Clearbluenon-aqueoussolution.

4. ClinicalParticulars

4.1 TargetSpecies

Sheep.

4.2 Indicationsforuse,SpecifyingtheTargetSpecies

Forthetreatmentandcontrolofheadflies,andtreatmentofticksandbiting

lice.Forthepreventionandtreatmentofblowflystrike.

4.3 Contraindications

Nottobeusedinlambslessthanoneweekold.

Forthepreventionofblowflystrike;donotadministertoanimalsoflessthan

12.5kgbodyweight.

Avoidtreatingveryyounglambsiftheweatherisunseasonablyhot.

4.4 SpecialWarningsforEachTargetSpecies

None

Issued:June2012

AN:00524/2011

4.5 SpecialPrecautionsForUse

i)Specialprecautionsforuseinanimals

Ectofly12.5mg/mlPour-OnSolutionforSheepminimisesmothering-up

problemsaftertreatment.However,caremustbetakennottoapplythe

productrighttothelamb’stail,asaewerecognisesayounglambpartlybythe

smellofthetailarea.

Blowfliesareattractedbydirty,dampwooloropenwounds.Themore

commonsiteforflystrikeistherumpduetosoilingcausedbydiarrhoeaand

urinestaining.TheefficacyofEctofly12.5mg/mlPour-Onisreducedinthe

presenceofsoiledordirtywool.Therefore,sheepmustbecrutched(dagged)

regularlyandappropriatewormcontrolmeasuresemployed.

Takecarenottoapplyproductinthesheep’seyes.Thisprecautionshouldbe

observedparticularlywhentreatingbreedswithlittlewoolontheirheads.

Fulloperatingandmaintenanceinstructions,includingdetailsontheuseof

nozzlesaresuppliedwitheachapplicatorgun.Pleasereadcarefullybefore

use.Maintainapplicatorguncarefullytoensureaccuratedosage.

Forexternaluseonly.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Makesurewhenattachingtherecommendedapplicatorgunontothe

containerthatthecoiledretainerissecuredontothecapandtheapplicator.

Useinawell-ventilatedareaandavoidinhalingthevapour.

Weareyeprotection,protectiveclothing,rubberglovesandbootswhen

applyingtheproduct.

Wearadisposablefacemaskwhenapplyingasafan-sprayforthe

preventionofblowfly-strike.

Donoteat,drinkorsmokewhilstusingtheproduct.

Washsplashesfromskinandeyesimmediatelywithplentyofcleanwater.

Ifirritationpersistsseekmedicaladviceimmediatelyandshowthepackage

leaflettothephysician.

Removecontaminatedclothingimmediatelyandwashexposedskinwith

plentyofcleanwater.

Washhandsandexposedskinbeforeeating,drinkingorsmokingandafter

work.

Issued:June2012

AN:00524/2011

iii)Otherprecautions

Asaprecautionarymeasuresheepmustbekeptawayfromwatercourses

foratleast12hoursfollowing treatment(seesection5.3,‘Environmental

properties’).

Longtermeffectsondunginsectscausedbycontinuousorrepeateduseof

pyrethroidectoparasiticidescannotbeexcluded.Thereforerepeated

treatmentofanimalsonthesamepasturewithapyrethroid-containing

productwithinaseasonshouldonlybegivenintheabsenceofalternative

treatmentsorapproachestomaintainanimal/flockhealth,asadvisedbya

veterinarian.

4.6 AdverseReactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancyorlactation

Maybeusedduringpregnancy.Pregnantewesmustbehandledwithcare.

Seesection4.11.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Theproductmustbeappliedonlywiththerecommendedapplicatorgun,as

theproductmayhaveadetrimentaleffectoncertaincomponentsof

conventionaldosingguns.

4.9 Amountstobeadministeredandadministrationroute

Oncompletionofeachtreatmentcycleoftheproductandbeforethedosing

gunisstored,immediatelyexpelanyremainingproductinthedosinggun.

Administerbymeansoftherecommendedapplicatorgunasfollows:

Blowflies:

Preventionofblowflystrike

Bodyweight Dose Dosesperlitre

Upto25kg* 20ml 50

25to40kg 30ml 33

Over40kg 40ml 25

*Donotadministertoanimalsoflessthan12.5kgbodyweight.

Applyasafan-spraytothesurfaceofthefleeceonthebackandhindquarters

ofthesheepusingthePour-OnGunfittedwiththefan-spraynozzle.Halfthe

doseshouldbeappliedtotheshoulders,backandflanks,andhalftothe

rump.Thedistancebetweenthenozzleandthefleeceshouldbe

Issued:June2012

AN:00524/2011

approximately20cm.Eachdosewillrequire2or3sweepstoapply.THE

PRODUCTWILLPREVENTBLOWFLYSTRIKEONLYONAREAS

COVEREDBYSPRAY.Oneapplicationwillgive6-8weeksprotection.Re-

treatasrequired.

Treatmentofblowflystrike

Applydirectlytoalltheaffectedpartsattherateof2.5mlper100 –150cm 2

(roughlythesizeofahand).TheT-barnozzleshouldbeused.Moststrikes

willrequire5-10ml.Ensurethatallaffectedpartsaretreated.Asingle

applicationissufficienttoensurethatlarvaeareexpelledandkilledwithina

fewhours.

Lice:5mlper20kgbodyweightuptoamaximumof20ml.

Bodyweight Dose Dosesperlitre

Upto20kg 5ml 200

21to40kg 10ml 100

41to60kg 15ml 66

Over60kg 20ml 50

Usingthestraightnozzleontheapplicatorgun,applyasapin-streamfromthe

shoulderstotherumpalongthemiddleofthebackline.

Sheepmaybetreatedoff-shearsoratanytimeduringtheyear.

Issued:June2012

AN:00524/2011

Ticks:Adultsheepandlambsgreaterthan10kg:10mlper20kg

bodyweight,uptoamaximumof40ml.Lambsunder10kg:5mlfollowed3

weekslaterbya10mlapplication.

Bodyweight Dose Dosesperlitre

Upto10kg 5ml 200

11to20kg 10ml 100

21to40kg 20ml 50

41to60kg 30ml 33

Over60kg 40ml 25

UsingthestraightnozzleonthePour-OnGun,applyasapin-streamfromthe

crownoftheheadtothetopoftherump.

Headflies:5mlperanimalirrespectiveofsize.

ApplytothetopoftheheadbetweentheearsusingtheT-barnozzle.

Takecarenottoapplyproductinthesheep’seyes.

Oneapplicationbeforethestartoftheheadflyseasonwillgiveupto4weeks

protection.Re-treatasrequired.

Thisproductcontainsadyetoaidintheidentificationoftreatedanimals.The

colouristemporaryandwillfadefromthefleecewithin48hoursofapplication.

4.10 Overdose(symptoms,emergencyprocedure,antidotes),ifnecessary

Toxicsignsinmammalsaretremors,hyperexcitability,salivation,

choreoathetosisandparalysis,rarelyleadingtodeath.Usually,thesigns

disappearrapidlyandtheanimalsrecover,generallywithinaweek.

Thereisnospecificantidotebutsymptomatictherapycanbegivenif

considerednecessary.

Issued:June2012

AN:00524/2011

4.11WithdrawalPeriods

Meatandoffal:8days.

Milk:Nottobeadministeredtoanimalsproducingmilkforhuman

consumption,norinpregnantdairyeweswithin2weekspriortoparturition.

5. PharmacologicalProperties

ATCvetcode:QP53AC08

Pharmacotherapeuticgroup:ectoparasiticidesfortopicaluse,incl.Insecticides.

5.1PharmacodynamicProperties

Cypermethrinisaneuropoisonactingontheaxonsintheperipheralandcentral

nervoussystemofinsectsbyinteractingwithsodiumchannels.

5.2PharmacokineticParticulars

Syntheticpyrethroidsaregenerallymetabolisedinmammalsthroughester

hydrolysis,oxidationandconjugationandthereisnotendencytoaccumulatein

tissues.

5.3EnvironmentalProperties

Cypermethrinismoderatelypersistentandnon-mobileinsoil.Itisextremelytoxicto

aquaticinvertebrates.Cypermethrinistoxictodunginsectsandtohoneybees.Long

termeffectsondunginsectscausedbycontinuousorrepeateduseoftheproduct

cannotbeexcluded.

6. PharmaceuticalParticulars

6.1 Listofexcipients

GreenSDye(E142)

Diethyleneglycolmonobutylether

6.2 Incompatibilities

Noneknown.

6.3 Shelf-Life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:24months.

Shelflifeafterfirstopeningoftheimmediatepackaging:3months.

Issued:June2012

AN:00524/2011

6.4 SpecialPrecautionsforStorage

Donotstoreabove25°C.Protectfromdirectsunlight.Storeintightlyclosed

originalcontainer.

Storeawayfromfood,drinkandanimalfeedingstuffs.

6.5 NatureandCompositionofImmediatePackaging

Whitehigh-densitypolyethyleneflatbottomcontainerswithpolypropylene

closuresandinductionheat-sealedwadding,at1litre,2.5litreand5litrepack

sizes.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

EXTREMELYDANGEROUStoaquaticinvertebrates.Donotcontaminate

ponds,waterwaysorditcheswiththeproductoremptycontainer.

7. MarketingAuthorisationHolder

CrossVetpharmGroupLtd.

BroomhillRoad,

Tallaght,

Dublin24

Ireland

8. MarketingAuthorisationNumber

Vm12597/4055

9. DateofFirstAuthorisation

5April2011

10. DateofRevisionoftheText

June2012