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 d