SUMMARY OF PRODUCT CHARACTERISTICS

CLiK Extra 65 mg/mlPour-OnSuspension for Sheep

Each ml contains:

Active substance:

Dicyclanil65 mg

Excipients:

Methyl parahydroxybenzoate (E218)	1.50 mg
Propyl parahydroxybenzoate	3.00 mg
Butylated hydroxytoluene	0.50 mg
Ponceau 4R	0.05 mg

For the fulllistofexcipients,seesection6.1

Pink coloured suspension

Sheep

Prevention of blowfly strike on sheep caused byLuciliasericata or Wohlfahrtia magnifica.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

The product is best applied before an anticipated blowfly challenge, or when a blowfly challenge is identifiedon,or in the vicinity of, the farm. Establishedstrikes may require a separate treatment witha knockdown insecticide.

Itis recommended that animals with dirty back-endsare dagged or crutched prior to application. Ifdagging or crutching is undertaken in the weeks following application, these animals should be re-treated, otherwise protection could be lost.

Do not apply during heavy rainfall, or when such conditions are expected. The resulting wash out may reduce the protection period.

Special precautions for use in animals

None

Special precautions to be taken by the person administering the veterinary medicinal product to animals

• Redness and irritation may develop after skin or eye contact with the product.

• Contact with skin and eyes should be avoided.

• Personal protective equipment consisting of synthetic rubber gloves and PVC trousers should be worn when handling the product.

• In case of skin contact remove contaminated clothing and thoroughly wash the affected parts of the body with soap and water.

• In case of eye contact wash immediately with clean water.

• Always wash hands and exposed skin with soap and water after work.

• Do not eat, drink or smoke whilst using the product.

• Residues remain on the fleece for some time after treatment, therefore, it is good agricultural practice to minimise handling of sheep after treatment. If you need to handle sheep within 3 months after treatment, wear synthetic rubber gloves and long trousers or coveralls. If sheep are wet wear waterproof trousers.

• Do not shear sheep in the 3 months after treatment.

Other precautions

Treated sheep mustbe kept away from watercourses for at least one hour after treatment. There is a seriousrisk to aquatic life if this advice is not followed.

None known

The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Use according to the benefit/risk assessment by the responsible veterinarian.

Laboratory studies in rats and rabbits have not produced anyevidenceof teratogenic, foetotoxic ormaternotoxic effects.

None known

For external use only

The veterinary medicinal productis applied according to the following recommendations:

Bodyweight (kg)	Dose Volume (ml)
10-20	20
21-30	24
31-50	30
>50	36

(Guide dose volumes correspond to 0.6–2ml [39–130 mg dicyclanil]per kg bodyweight.)

To ensure administrationofacorrect dose, bodyweightshould be determined as accurately aspossible; accuracy of the dosing device should be checked.

If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under-oroverdosing.

Recommended for treatment in sheepwithanywoollength,including off-shears.

Shake the container well before use.

Do not dilute with water.

The veterinary medicinal product must be applied with a manual or automatic dosing gun, fitted with a spray nozzle, which guarantees the correct spreading of the product on the fleece. Best results will be achieved by holding the gun approximately 45 cm from the sheep during application. Apply as a fan spray alongthe spine of the animal in bands at least 10 cm wide from the middle of the shoulders and in an arc around the crutch and tail. Half the dose should be applied along the spine with the remainder over the tail and crutch area.

The veterinary medicinal product should be applied before, oratthestartof, predicted fly activity.

The veterinary medicinal product will protect against fly strike for 19 weeks.Itisgoodagriculturalpractice to check animals regularly for fly strike.

An overdose of up to at least 4 times the recommended dose does not lead to any signs of local or systemic intolerance.

No antidote is known.

Meatandoffal: 40 days

Not authorised for use in animals producing milk for human consumption.

Pharmacotherapeutic group: Other ectoparasiticides for topical use.

ATCvetcode:QP53AX24.

Dicyclanil prevents the moult from the first to the second larval instar of Lucilia spp. . It is less effective against later larval stages and does not have any adulticidal action. The modeof action of dicyclanil is believed to be similar to that of the triazine compounds.

In studies with the 50mg/mlformulation, after 7 days post dosing, approximately 5% of the dose wasabsorbed and eliminated in urine and faeces. Peak blood levels were observed between 12 and 48h post dose, accounting for <0.025 mg dicyclanil equivalents/kg.

In experimental metabolism studies, absorbed drugwas widely distributed throughout the body. Longest half lives were found in liverandkidneybeing13and10daysrespectively.Inmuscle,fatand wool, unchanged dicyclanil was found to be the major residue, whereas in liver and kidney the descyclopropyl dicyclanil was found to be the major residue together with unchanged dicyclanil.

5.3 Environmental properties

Dicyclanil has the potential to cause harmful effects on aquatic invertebrates and dung fly larvae.

Following use of this product, levels of dicyclanil potentially harmful to dung fly larvae have been shown to be excreted in faeces for approximately 4 weeks. Faeces from treated animals may temporarily reduce the abundance of dung fly larvae which may impact on dung degradation.

Methylparahydroxybenzoate(E218)

Propyl parahydroxybenzoate

Butylatedhydroxytoluene

Ponceau 4R

Polysorbate 20

AcrylicacidcopolymerDisodium edetate Distilled monoglycerides

Triglycerides, medium-chainPropylene glycol

Sodium hydroxidePurified water

In the absence of compatibility studies, this veterinarymedicinal product must not be mixed withother veterinary medicinal products.

Shelf life of the veterinary medicinal product as packaged for sale: 30 months Shelf life after first opening the immediate packaging: 1 year

6.4 Special precautionsfor storage

Store in the original container.

Keepthe containertightly closed, away from food, drink and animal feedstuffs. Protect from direct sunlight.

Protect from frost

1 L, 2.5 L and 5 L white opaque polyethylene back pack containers filled with 0.8 L, 2.2 L and 5 L, respectively, and closed with a polypropylene screw cap.

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Harmful to aquatic invertebrates.

Do not contaminate ponds or other waterways with product or empty containers.

Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL

Vm00879/4003

21 October 2016

10. DATE OF REVISION OF THE TEXT

October 2016

Approved: 21/10/2016