Ectofly

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
    Ireland
  • 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

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

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