Crovect 1.25% w/v Pour-on Solution for Sheep

Composition

Active substance(s): % w/v

Cypermethrin tech. (cis:trans 80:20) 1.25

Excipient(s):

Lissamine Green B (E142) 0.02

For a full list of excipients, see section 6.1.

6.1 List of excipients

Lissamine Green B (E142)

2-(2-Butoxyethoxy) ethanol

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Pharmaceutical form

Pour-on solution.

Clear blue non-aqueous solution.

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Pharmacological properties

Pharmacotherapeutic group: ectoparasiticides for topical use, incl. Insecticides

ATCvet code: QP53AC08

5.1 Pharmacodynamic properties

Cypermethrin is a neuropoison acting on the axons in the peripheral and central nervoussystem of insects by interacting with sodium channels.

5.2 Pharmacokinetic particulars

Synthetic pyrethroids are generally metabolised in mammals through ester hydrolysis,oxidation and conjugation and there is no tendency to accumulate in tissues.

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Target species

Sheep

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Indications

For the treatment and control of headflies. For the treatment of tick infestation with a persistent efficacy of 10 weeks (the majority of ticks killed within 3 hours) and treatmentof biting lice in sheep. For the prevention and treatment of blowfly strike in sheep.

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Dosage

On completion of each treatment cycle of the product and before the dosing gun isstored, immediately expel any remaining product in the dosing gun.

Failure to use the product as directed may result in suboptimal parasite control.

Administer by means of a Crovect Pour-On Gun as follows:

Blowflies:

Prevention of blowfly strike

*Do not administer to animals of less than 12.5 kg bodyweight.

Apply as a fan-spray to the surface of the fleece on the back and hindquarters of the sheep using the Pour-On Gun fitted with the fan-spray nozzle. Half the dose should beapplied to the shoulders, back and flanks, and half to the rump. The distance between the nozzle and the fleece should be approximately 20 cm. Each dose will require 2 or 3 sweeps to apply.

THE PRODUCT WILL PREVENT BLOWFLY STRIKE ONLY ON AREASCOVERED BY SPRAY.

One application will give 6-8 weeks protection. Re-treat as required.

Treatment of blowfly strike

Apply directly to all the affected parts at the rate of 2.5 ml per 100 –150 cm2 (roughly thesize of a hand). The T-bar nozzle should be used. Most strikes will require 5-10 ml.

Ensure that all affected parts are treated. A single application is sufficient to ensure thatlarvae are expelled and killed within a few hours.

Lice: 5 ml per 20 kg bodyweight up to a maximum of 20 ml.

Bodyweight | Dose | Doses per litre

Up to 20 kg | 5 ml | 200

21 to 40 kg | 10 ml | 100

41 to 60 kg | 15 ml | 66

Over 60 kg | 20 ml | 50

Using the straight nozzle on the Pour-On Gun, apply as a pin-stream from the shoulders to the rump along the middle of the backline. Sheep may be treated off-shears or at anytime during the year.

Ticks: Adult sheep and lambs greater than 10 kg: 10 ml per 20 kg bodyweight, up to amaximum of 40 ml. One treatment will give 10 weeks cover.

Lambs under 10 kg: 5 ml followed 3 weeks later by a 10 ml application.

Bodyweight | Dose | Doses per litre

Up to 10 kg | 5 ml | 200

11 to 20 kg | 10 ml | 100

21 to 40 kg | 20 ml | 50

41 to 60 kg | 30 ml | 33

Over 60 kg | 40 ml | 25

Using the straight nozzle on the Pour-On Gun, apply as a pin-stream from the crownof the head (see section 4.5 (i) regarding avoidance of the eyes) to the top of the rump.

Headflies: 5 ml per animal irrespective of size.

Apply to the top of the head between the ears using the T-bar nozzle. Take care not to apply product in the sheep’s eyes.

One application before the start of the headfly season will give up to 4 weeks protection.

Re-treat as required.

This product contains a blue dye to aid in the identification of treated animals. The colouris temporary and will fade from the fleece within 48 hours of application.

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Contraindications

Not to be used in lambs less than one week old.

Avoid treating very young lambs if the weather is unseasonably hot.

For the prevention of blowfly strike; do not administer to animals of less than 12.5 kg bodyweight.

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Adverse reactions

None known

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Warnings

i. Special precautions for use in animals

Crovect minimises mothering-up problems after treatment. However, care must be taken not to apply the product right to the lamb’s tail, as a ewe recognises a younglamb partly by the smell of the tail area.

Blowflies are attracted by dirty, damp wool or open wounds. The most common site forfly strike is the rump due to soiling caused by diarrhoea and urine staining. The efficacy of Crovect is reduced in the presence of soiled or dirty wool. Therefore, sheepmust be crutched (dagged) regularly and appropriate worm control measures employed.

Take care not to apply product in the sheep’s eyes. This precaution should be observedparticularly when treating breeds with little wool on their heads.

Full operating and maintenance instructions, including details on the use of nozzles are supplied with each Pour-On Gun. Please read carefully before use. Maintain gun carefully to ensure accurate dosage.

Prior to application, check the Pour-On gun for correct operation and calibration.

For external use only

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

Make sure when attaching the Crovect Pour-On gun onto the container that the coiledretainer is secured onto the cap and the applicator.

Wear eye protection, protective clothing, rubber gloves and boots when applying theproduct.

Wear a disposable face-mask when applying as a fan-spray for the prevention ofblowfly-strike.

Cypermethrin can be skin sensitizing and eye irritating. In a few instances operators may experience a mild tingling sensation of the skin when using the product. Wash splashes from skin immediately and thoroughly with plenty of clean water. If irritation persists seek medical advice immediately. If product splashes in eyes, flush thoroughly with water for 10 to 15 minutes and seek medical advice immediately.

Remove contaminated clothing immediately and wash exposed skin with plenty of cleanwater.

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

Wash hands and exposed skin before eating, drinking or smoking and after work.Use in a well-ventilated area and avoid inhaling the vapour.

iii. Other precautions

As a precautionary measure sheep must be kept away from watercourses for at least one hour following treatment.

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Use during pregnancy, lactation or lay

No restrictions, but handle pregnant sheep with care.

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Interactions

The product must be applied only with the Crovect Pour-On Gun, as the product mayhave a detrimental effect on certain components of conventional dosing guns.

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Overdose

Toxic signs in mammals are tremors, hyperexcitability, salivation, chorea, athetosis and paralysis. The signs disappear rapidly and the animals recover, generally within aweek.

There is no specific antidote but symptomatic therapy can be given if considerednecessary.

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Special warnings

None

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Withdrawal period

Meat and offal: 8 days

Milk: 5 days

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Incompatibilities

None known

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Immediate packaging

White, opaque, high density polyethylene bottle containing 0.8, 2.2 or 5 litres with either a blue, polyethylene cap (screw-fit) and an integral polyethylene induction seal or a blue,polypropylene spouted cap (screw-fit) with a hinged tamper evident lid (snap-fit).

Not all pack sizes may be marketed.

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Storage

Do not store above 25°C. Protect from direct sunlight.Store in tightly closed original container.

Store away from food, drink and animal feeding stuffs.

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Shelf life

Shelf life of the 0.8 litre and 2.2 litre veterinary medicinal product as packaged forsale: 18 months.

Shelf life of the 5.0 litre veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening of the immediate packaging: 3 months.

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Disposal of unused product

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

Extremely dangerous to fish and other aquatic life. Do not contaminate ponds,waterways or ditches with the product or empty container.

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Additional information

Vm 52127/5079

9 DATE OF FIRST AUTHORISATION

11 March 2001

10 DATE OF REVISION OF THE TEXT

April 2025

Approved 29 April 2025

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Registration holder

Elanco GmbH

Heinz-Lohmann Strasse 4

D-27472 Cuxhaven

Groden

Germany

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