A5datasheetECTOFLYROI

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PRODUCT INFORMATION Bimeda ® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 www.bimeda.ie See reverse side for Administration and Dosage. PACKAGING ECTOFLY 1.25% w/v Pour-On Solution LIST NO. UNIT PACKAGE CASE SIZE 8ECT008 5L 4 Cypermethrin INDICATIONS For convenient and efficient ectoparasite control in sheep For the treatment and control of headflies use T bar Nozzle For the treatment of ticks and biting lice in sheep use straight nozzle For the prevention of blowfly strike use the fanspray nozzle For the treatment of blowfly strike use T Bar nozzle. BENEFITS 6 – 8 week blowfly strike prevention Proven Formulation Short 8 day meat withhold period Can be used all year round Contains 48 hour blue dye

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PRODUCT INFORMATION

Bimeda® Broomhill RoadTallaghtDublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 www.bimeda.ie

See reverse side for Administration and Dosage.

PACKAGING

ECTOFLY 1.25% w/v Pour-On Solution

LIST NO. UNIT PACKAGE CASE SIZE8ECT008 5L 4

Cypermethrin

INDICATIONS• Forconvenientandefficientectoparasite controlinsheep• Forthetreatmentandcontrolofheadflies use T bar Nozzle • For the treatment of ticks and biting lice in sheepusestraightnozzle• Forthepreventionofblowflystrikeusethe fanspraynozzle• Forthetreatmentofblowflystrikeuse T Bar nozzle. BENEFITS• 6–8weekblowflystrikeprevention• Proven Formulation• Short8daymeatwithholdperiod• Canbeusedallyearround• Contains48hourbluedye

TECHNICAL INFORMATION

www.bimeda.ie

ECTOFLY 1.25% w/v Pour-On Solution for Sheep

1. PRESENTATIONA clear blue non-aqueous solution containing 1.25%w/vHighCis(80:20)CypermethrinforthepreventionandtreatmentofBlowflyStrike,Lice,TicksandHeadfliesonSheep.

2. CLINICAL PARTICULARS2.1 Target Species Sheep.

2.2 Indications for use, Specifying the Target SpeciesForthetreatmentandcontrolofheadflies,andtreatmentofticksandbitingliceinsheep.Forthepreventionandtreatmentofblowflystrikeinsheep.

2.3 ContraindicationsNottobeusedinlambslessthanoneweekold.Forthepreventionofblowflystrike;donotadministertoanimalsoflessthan12.5kgbodyweight.Avoidtreatingveryyounglambsiftheweatherisunseasonablyhot.

2.4 Special Warnings for Each Target Species None

2.5 Special Precautions For Usei) Special precautions for use in animalsEctofly1.25%w/vPour-Onminimisesmothering-upproblemsaftertreatment.However,caremustbetakennottoapplytheproductrighttothelamb’stail,asaewerecognisesayounglambpartlybythesmell of the tail area.Blowfliesareattractedbydirty,dampwooloropenwounds.Themorecommonsiteforflystrikeistherumpduetosoilingcausedbydiarrhoeaandurinestaining.TheefficacyofEctofly1.25%w/vPour-Onisreducedinthepresenceofsoiledordirtywool.Therefore,sheepmustbecrutched(dagged)regularlyandappropriatewormcontrolmeasuresemployed.

Takecarenottoapplyproductinthesheep’seyes.Thisprecautionshouldbeobservedparticularlywhentreatingbreedswithlittlewoolontheirheads.Fulloperatingandmaintenanceinstructions,includingdetailsontheuseofnozzlesaresuppliedwitheachapplicatorgun.Pleasereadcarefullybeforeuse.Maintainapplicatorguncarefullytoensure accurate dosage.

Forexternaluseonly.

ii) Special Precautions to be taken by the person administering the product to animals

Makesurewhenattachingtherecommendedapplicatorgunontothecontainerthatthecoiledretainerissecuredontothecapandtheapplicator.

Weareyeprotection,protectiveclothing,rubberglovesandbootswhenapplyingtheproduct.

Wearadustmaskwhenapplyingasafan-sprayforthepreventionofblowfly-strike.

Washsplashesfromskinandeyesimmediatelywithplentyofcleanwater.Ifirritationpersistsseekmedicaladviceimmediately

Removecontaminatedclothingimmediatelyandwashexposedskinwithplentyofcleanwater.

Donoteat,drinkorsmokewhilstusingtheproduct.

Washhandsandexposedskinbeforeeating,drinkingorsmokingandafterwork.

Useinawell-ventilatedareaandavoidinhalingthevapour.

TECHNICAL INFORMATION

www.bimeda.ie

ECTOFLY 1.25% w/v Pour-On Solution for Sheep

iii) Other precautions

Asaprecautionarymeasuresheepmustbekeptawayfromwatercoursesforatleastonehourfollowingtreatment(seesection5.3,‘Environmentalproperties).

2.6 Adverse Reactions(frequencyandseriousness) Noneknown.

2.7 Use during pregnancy or lactation

Norestrictions.Pregnantewesmustbehandledwithcare.

2.8 Interaction with other medicinal products and other forms of interaction

Theproductmustbeappliedonlywiththerecommendedapplicatorgun,astheproductmayhaveadetrimentaleffectoncertaincomponentsofconventional dosing guns.

2.9 Amounts to be administered and administration route

Oncompletionofeachtreatmentcycleoftheproductandbeforethedosinggunisstored,immediatelyexpelanyremainingproductinthedosinggun.

Administerbymeansoftherecommendedapplicatorgunasfollows:Blowflies:

PREVENTION OF BLOWFLY STRIKE

Bodyweight Dose Doses per litreUpto25kg* 20ml 5025 to 40 kg 30 ml 33Over40kg 40ml 25

*Donotadministertoanimalsoflessthan12.5kgbodyweight.

Applyasafan-spraytothesurfaceofthefleeceonthebackandhindquartersofthesheepusingthePour-OnGunfittedwiththefan-spraynozzle.Halfthedoseshouldbeappliedtotheshoulders,backandflanks,andhalftotherump.Thedistancebetweenthenozzleandthefleeceshouldbeapproximately20cm.Eachdosewillrequire2or3sweepstoapply.THEPRODUCTWILLPREVENTBLOWFLYSTRIKEONLYONAREASCOVEREDBYSPRAY.Oneapplicationwillgive6-8weeksprotection.Re-treatasrequired.

Treatment of blowfly strike

Applydirectlytoalltheaffectedpartsattherateof2.5mlper100–150cm2(roughlythesizeofahand).TheT-barnozzleshouldbeused.Moststrikeswillrequire5-10ml.Ensurethatallaffectedpartsaretreated.Asingleapplicationissufficienttoensurethatlarvaeareexpelledandkilledwithinafewhours.

20 cm

20 ml

20 ml

10 ml

10 ml

10 ml

10 ml

10 ml

10 ml

Coverage withspray

TECHNICAL INFORMATION

www.bimeda.ie

ECTOFLY 1.25% w/v Pour-On Solution for Sheep

Lice:5mlper20kgbodyweightuptoamaximumof 20 ml.

Bodyweight Dose Doses per litreUpto20kg 5ml 20021 to 40 kg 10 ml 10041 to 60 kg 15 ml 66Over60kg 20ml 50

Using the straight nozzle ontheapplicatorgun,applyasapin-streamfromtheshoulderstotherumpalong the middle of the backline.

Sheepmaybetreatedoff-shearsoratanytimeduringtheyear.

Ticks:Adultsheepandlambsgreaterthan10kg:10mlper20kgbodyweight,uptoamaximumof40ml.Lambsunder10kg:5mlfollowed3weekslaterbya10mlapplication.

Bodyweight Dose Doses per litreUpto10kg 5ml 20011 to 20 kg 10 ml 10021 to 40 kg 20 ml 5041 to 60 kg 30 ml 33Over60kg 40ml 25

Using the straight nozzle on thePour-OnGun,applyasapin-streamfromthecrownoftheheadtothetopoftherump.

Headflies:5mlperanimalirrespectiveofsize.Applytothetopoftheheadbetweentheearsusingthe T-bar nozzle.

Takecarenottoapplyproductinthesheep’seyes.Oneapplicationbeforethestartoftheheadflyseasonwillgiveupto4weeksprotection.Re-treatasrequired.

Thisproductcontainsabluedyetoaidintheidentificationoftreatedanimals.Thecolouristemporaryandwillfadefromthefleecewithin48hoursofapplication.

2.10 OverdoseToxic signs in mammals are tremors, hyperexcitability,salivation,choreoathetosisandparalysis,rarelyleadingtodeath.Usually,thesignsdisappearrapidlyandtheanimalsrecover,generallywithinaweek.Thereisnospecificantidotebutsymptomatictherapycanbegivenifconsiderednecessary.

2.11 Withdrawal Periods Meatandoffal:8days. Milk: Not to be administered to animals producingmilkforhumanconsumption.

3. MARKETING AUTHORISATION HOLDER CrossVetpharmGroupLtd. Broomhill Road, Tallaght, Dublin 24, Ireland.

4. MARKETING AUTHORISATION NUMBER Vm12597/4055

5. DATE OF FIRST AUTHORISATION 5April2011

6. DATE OF THE REVISION OF THE TEXT April2011

AfullproductspcisavailableonrequestfromBimedaoralternativelycanbefoundontheVMDwebsite

LEGAL CATEGORYPOM-VPS