Medine.co.uk

Clik Extra 65 Mg/Ml Pour-On Suspension For Sheep

Issued: October 2016

AN: 00759/2015

SUMMARY OF PRODUCT CHARACTERISTICS


NAME OF THE VETERINARY MEDICINAL PRODUCT


CLiK Extra 65 mg/mlPour-OnSuspension for Sheep


QUALITATIVE AND QUANTITATIVE COMPOSITION


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


PHARMACEUTICAL FORM


Pink coloured suspension


CLINICAL PARTICULARS


Target species


Sheep


Indications for use, specifying the target species


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


Contraindications


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


Special warnings for each target species


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


Special precautions for use in animals


None


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


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.


Adverse reactions (frequency and seriousness)


None known


Use during pregnancy or lactation


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.


Interaction with other medicinal products and other forms of interaction


None known


Amounts to be administered and administration route


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.


Overdose (symptoms, emergency procedures, antidotes), if necessary


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.


Withdrawal period(s)


Meatandoffal: 40 days


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


PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Other ectoparasiticides for topical use.

ATCvetcode:QP53AX24.

Pharmacodynamic properties


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.



Pharmacokinetic particulars


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.


PHARMACEUTICAL PARTICULARS


List of excipients


Methylparahydroxybenzoate(E218)

Propyl parahydroxybenzoate

Butylatedhydroxytoluene

Ponceau 4R

Polysorbate 20

AcrylicacidcopolymerDisodium edetate Distilled monoglycerides

Triglycerides, medium-chainPropylene glycol

Sodium hydroxidePurified water


Incompatibilities


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


Shelf life


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


Nature and composition of immediate packaging


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.


Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products


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.


MARKETING AUTHORISATION HOLDER


Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL


MARKETING AUTHORISATION NUMBER

Vm00879/4003


DATE OF FIRST AUTHORISATION


21 October 2016


10. DATE OF REVISION OF THE TEXT


October 2016


Approved: 21/10/2016

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