SUMMARY OF PRODUCT CHARACTERISTICS

Dectospot 10 mg/ml Spot-on Solution forCattleand Sheep

2. QualitativeandQuantitativeComposition

_{ActiveSubstance mg/ml}

Deltamethrin 10.0

Forthefull list ofexcipients, seesection 6.1

3. PharmaceuticalForm

Spot-on Solution

A clearpalegold oilyliquid

4. Clinical Particulars

_{4.1 TargetSpecies}

Cattleand sheep.

_{4.2 Indications foruse, SpecifyingtheTarget Species}

As atopical application forthecontrol ofliceandflies on cattle; ticks, lice,keds and established blowflystrikeon sheep and liceand ticks on lambs.

On cattle:forthecontrolofboth sucking and bitinglice, includingDamalinia bovis, Solenopotes capillatus, Linognathus vituliand Haematopinus eurysternus on all ages ofcattleincludingdairycattleproducingmilk forhuman consumption. Also as an aid in thecontrol ofbothbitingand nuisanceflies includingHaematobia irritans, Stomoxys calcitrans, Musca speciesand Hydrotaea irritans.

On sheep: Forthecontrol ofticks Ixodes ricinus and ofliceand kedsand established blowflystrike.

_{On lambs:Forthecontrol ofticks Ixodes ricinus and liceBovicola ovis.}

_{4.3 Contraindications}

None.

_{4.4 SpecialWarnings forEachTargetSpecies}

Careshould betaken toavoid inaccuratedosing,misadministration ortoo frequentand repeated useofectoparasiticides from thesameclass overan extended period oftimeas thesepractices increasetherisk ofdevelopmentof resistanceand could ultimatelyresult in ineffectivetherapy.

_{4.5 SpecialPrecautionsForUse}

_{i)Special precautions forusein animals}

Forexternal useonly.

ii)SpecialPrecautions tobetakenbytheperson administeringtheproducttoanimals

Wearprotectiveclothing includingwaterproofapron and boots and impervious gloves wheneitherapplyingtheproduct orhandling recently treated animals.

Removeheavilycontaminated clothingimmediatelyand wash beforeuse. Wash splashes from skin immediatelywith soap and plentyofwater.

Wash hands and exposed skin afterhandlingthis product and beforemeals. Incaseofcontact with eyes,rinseimmediatelywith plentyofclean, running waterand seek medical advice.

Incaseofaccidental ingestion, wash out mouth immediatelywith plentyof waterand seek medical advice.

Do not smoke, drink oreat whilehandlingtheproduct.

This product contains deltamethrin which mayproducetingling, itchiness and blotchyredness on exposed skin. Ifyou feel unwell afterworkingwith this product, consultyourdoctorand show this label.

Advicetomedical practitioners:Adviceonclinical management is available from theNational PoisonsInformation Service.

_{iii)Otherprecautions}

Deltamethrin is verytoxicto dung fauna,aquaticorganisms and honeybees, is persistent in soils and mayaccumulatein sediments.

Therisk to aquaticecosystems and dung faunacan bereduced byavoiding too frequentand repeated useofdeltamethrin (and othersyntheticpyrethroids)in cattleand sheep, e.g. byusingonlyasingletreatment peryearon thesame pasture. Therisk to aquaticecosystems will befurtherreduced bypreventing treated sheep fromenteringwatercourses foronehourimmediatelyafter treatment.

_{4.6 AdverseReactions (frequencyand seriousness)}

Minorsigns ofdiscomfort havebeen seen in somecattleduringthe48 hoursafter treatment. This is ofno longterm detriment to theanimal.

4.7 Useduringpregnancyorlactation

No special precautions arerecommended.

_{4.8 Interaction with othermedicinal products and otherforms ofinteraction}

Do not mixanyotherinsecticideoracaricidewithDectospot Spot-on Solution.

_{4.9 Amounts to beadministered and administration route}

Theproduct should beapplied usingan appropriateapplication device:

- Forthe250ml and 500mlpresentations agraduated chamberattached to thecontaineris used.

- Forthe1 litreand 2.5 litrepresentations it is recommended to usean appropriateapplicator.

Therecommended useoftheapplication devices is illustrated below.

1. Useofthegraduatedchamberon the250ml and 500 ml containers:

2. Attachingthe1 and 2.5 litrecontainers to therecommended applicator:

Dose:

Cattle:10 ml

Sheep: 5ml

Lambs (under10 kgbodyweight or1 month ofage): 2.5ml

Administration: Applyasingledosewith thespecial dispenserpack orthe Dectospot Applicatorononespot on themid-lineofthebackat theshoulders as directed on dispenserorapplicatorgun pack. Forblowflystrikeon sheep,see followingspecificindication directions.

Liceon cattle: Oneapplication will generallyeradicateall lice. Complete clearanceofall licemaytake4 -5 weeks during which timelicehatch from the eggsand arekilled. A veryfew licemaysurviveon asmall minorityofanimals. Therefore, it maybenecessaryon rareoccasions to re-treat an animal 6 -8weeks later.

Flies on cattle:To control bitingand non-biting flies, frequencyoftreatment will depend on thenumbersand species offlies present. Wherehorn-flies predominate,good control can beexpectedfor4 -8 weeks. Treatment forfly control should not berepeated within fourweeks.

Ticks on sheep:Application to themid-point oftheshoulders will provideuseful control ofticks attaching to animals ofall ages, forup to 6 weeks aftertreatment.

Keds and liceon sheep: Application to themid-point oftheshoulders ofsheep in short orlongfleecewill reducetheincidenceofabitinglouseorked infestation overa4 -6week periodaftertreatment.

N.B. Forcontrol ofticks, keds and liceon sheep,thefleeceshould beparted and

Spot On applied to theskin oftheanimal.

When usingtheDectospot applicatorapplicationto theskin can beachieved by insertingtheT barto separatethefleeceand penetratedown to theskin level beforesqueezingtheapplicatorhandle.

Established blowflystrikeon sheep: Applydirectlyto themaggot infectedarea as soon as theflystrikeis seen. Oneapplicationwill ensureblowflylarvaeare killed in ashort time. Inthecaseofmoreadvanced strikelesions, clipping out of stained wool beforetreatment is advisable.

Liceand ticks on lambs: Application to themid-point oftheshoulders will provideuseful control ofticks forup to 6 weeksaftertreatment, andwill reduce theincidenceofbitingliceovera4-6 week periodaftertreatment.

_{4.10 Overdose}

Thereareno specificrecommendations in thecaseofoverdosage.

_{4.11 Withdrawal Periods}

Cattle(meat)– 17 days Cattle(milk)– zero hours Sheep (meat)– 35 days

This product is not authorised foruseinewes producingmilk forhuman consumption.

5. PharmacologicalProperties

ATCvet code: QP53AC11

Pharmacotherapeuticgroup: Ectoparasiticides, insecticides andrepellents.Pyrethrinsand pyrethroids

5.1. Pharmacodynamicproperties

Deltamethrin is asyntheticpyrethroid possessing pesticidal activity. It is oneofalarge familyofpyrethroid esters which haveevolved assyntheticanalogues oftheoriginal insecticidal extracts isolated from powdered pyrethrum flowers. Deltamethrin is an alpha-cyano pyrethroidand is amemberofthesecond generation ofpyrethroids in which theoverall stabilityofthemoleculeis improved with correspondinglyincreased resistanceto photo-andbio-degradation and enhanced insecticidalactivity. It is more potentlytoxicto insects and acarines becauseoftheslowerrateofmetabolism.

5.2. Pharmacokineticproperties

Theprecisemodeofinsecticidal activityofpyrethoids remains uncertain, but theyare potent neurotoxins in insects, causingfailurein sensorycoordination and disorganised motoractivity, hencethe'knock-down'effect. Pyrethroids aremetabolisedthrough oxidativeand neurotoxicpathways farmorerapidlyin mammals, so that neurotoxic effects can onlyoccurat dosages which aremanyorders ofmagnitudegreaterthan those required forpesticidal activity.

5.3 Environmental properties

Deltamethrin has thepotential to adverselyaffectnon-target organisms, both in water and in dung.Followingtreatment, excretion ofpotentiallytoxiclevels ofdeltamethrin maytakeplaceoveraperiod of2 to 4 weeks.Faeces containingdeltamethrin excreted onto pasturebytreated animals mayreducetheabundanceofdungfeeding organisms which mayimpact on thedungdegradation.

Deltamethrin is verytoxicto dung fauna,aquaticorganisms and honeybees, is persistent in soils and mayaccumulatein sediments.

6. PharmaceuticalParticulars

6.1 List ofexcipients

_{Triglycerides, medium chain}

_{6.2 Incompatibilities}

In theabsenceofcompatibilitystudies, this veterinarymedicinal productmust not bemixed with otherveterinarymedicinal products.

_{6.3 Shelf-Life}

Shelf-lifeoftheveterinarymedicinal product as packaged forsale: 2years.

Shelf-lifeafterfirst openingtheimmediatepackaging: 3 months

_{6.4 SpecialPrecautions forStorage}

Theveterinarymedicinal product does not requireanyspecial temperature storageconditions. Keep thecontainerin theoutercarton in order to protectfrom light.

Storein tightlyclosed original containerawayfrom food, drink and animal feedingstuffs.

_{6.5 Natureand Contents ofImmediatePackaging}

Carton containing one 250 or500 ml natural high-densitypolyethylenebottlewith internal graduated calibration chamberwithblack plasticheat-sealedscrewcap.

Carton containing one1 litreor one or two 2.5 litrewhitehigh densitypolyethyleneflexipack with white polypropyleneclosuresand induction heat-sealedscrew-capand spouted cap for connection to applicator.

Not all pack sizes maybemarketed.

6.6 Special precautions forthedisposal ofunused veterinarymedicinal product orwastematerial derivedfrom theuseofsuch products

Dangerous to fish and otheraquaticlife. Do not contaminateponds, waterways or ditches with theproductorused container.

Anyunused veterinarymedicinal product orwastematerials derivedfrom such veterinarymedicinal products should bedisposed ofin accordancewith local requirements.

7. Marketing Authorisation Holder

Cross Vetpharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

Ireland

8. Marketing Authorisation Number

Vm 12597/4068

9. Date of First Authorisation

27 March 2015

10. Date of Revision of the Text

May 2016

Approved: 25 May 2016