Fly Off 12.5 mg/ml Pour-on Solution for Sheep

Composition

Each ml contains:

Active substance:

Cypermethrin tech. (cis:trans / 80:20) 12.5 mg

Excipient:

Clear blue non-aqueous solution

3

Pharmacological properties

4.1 ATCvet code:

QP53AC08

4.2 Pharmacodynamics

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

4.3 Pharmacokinetics

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

Cypermethrin is extremely toxic to aquatic and dung organisms and is persistent in soils. Long term effects on dung insects caused by continuous or repeated use of the veterinary medicinal product cannot be excluded.

Cypermethrin is persistent, toxic and may have the potential to bioaccumulate, Cypermethrin is thus possibly a PBT compound. Cypermethrin has been taken up on the list of 'priority substances' (Directive 2013/39/EU), which means that its presence in water bodies is monitored regularly.

3

Target species

Sheep.

3

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 treatment of biting lice in sheep. For the prevention and treatment of blowfly strike in sheep.

3

Dosage

Pour-on use.

On completion of each treatment cycle of the veterinary medicinal product and before the dosing gun is stored, immediately expel any remaining veterinary medicinal product in the dosing gun.

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.

Administer by means of the recommended applicator gun as follows:

Blowflies:

Prevention of blowfly strike

Bodyweight | Dose | Doses per litre

Up to 25 kg* | 20 ml | 50

25 to 40 kg | 30 ml | 33

Over 40 kg | 40 ml | 25

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

The dose should be limited to a maximum dose of 40 ml per animal

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 be applied 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 distance between the nozzle and the fleece should be approximately 20 cm. Each dose will require 2 or 3 sweeps to apply.

THE VETERINARY MEDICINAL PRODUCT WILL PREVENT BLOWFLY STRIKE ONLY ON AREAS COVERED BY SPRAY. One application will give 6-8 weeks protection.

Treatment of blowfly strike

Apply directly to all the affected parts at the rate of 2.5 ml per 100 –150 cm2 (roughly the size 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 that larvae 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 applicator 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 any time during the year.

Ticks: Adult sheep and lambs greater than 10 kg: 10 ml per 20 kg bodyweight, up to a maximum 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 crown of the head (see section 3.5 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 veterinary medicinal product in the sheep’s eyes.

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

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

3

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.

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

3

Adverse reactions

None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

Care must be taken not to apply the veterinary medicinal product right to the lamb’s tail, as a ewe recognises a young lamb partly by the smell of the tail area.

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

Take care not to apply veterinary medicinal product in the sheep’s eyes. This precaution should be observed particularly 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.

For external use only.

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

The veterinary medicinal product is harmful if swallowed.

Do not eat, drink or smoke whilst using the veterinary medicinal product. Wash hands immediately after use.

In case of accidental ingestion or mouth contact, immediately rinse the mouth with plenty of water and seek medical advice.

The veterinary medicinal may cause skin, eye or respiratory irritation, and may cause hypersensitivity reactions.

Avoid skin and/or eye contact.

Use in a well-ventilated area and avoid inhaling the vapour.

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

Wear eye protection, protective clothing, rubber gloves and boots when applying the veterinary medicinal product and handling the animal until the veterinary medicinal product has dried.

Make sure when attaching the recommended applicator gun onto the container that the coiled retainer is secured onto the cap and the applicator.

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

Wash splashes from skin and eyes immediately with plenty of clean water. If irritation persists seek medical advice immediately and show the package leaflet to the physician.

Avoid children from getting access to the veterinary medicinal product or treated animals.

Special precautions for the protection of the environment:

Cypermethrin is extremely toxic to aquatic and dung organisms As a precautionary measure sheep must be kept away from watercourses for at least 12 hours following treatment.

Long term effects on dung insects caused by continuous or repeated use of pyrethroid ectoparasiticides cannot be excluded.

Given the risks to the environment the use of the veterinary medicinal product should be limited to one treatment per year per pasture.

3

Use during pregnancy, lactation or lay

Pregnancy:

May be used during pregnancy. Pregnant ewes must be handled with care. See section 3.12.

3

Interactions

The veterinary medicinal product must be applied only with the recommended applicator gun, as the veterinary medicinal product may have a detrimental effect on certain components of conventional dosing guns.

3

Overdose

Toxic signs in mammals are tremors, hyperexcitability, salivation, chorea, athetosis and paralysis, rarely leading to death. Usually, the signs disappear rapidly and the animals recover, generally within a week.

There is no specific antidote, but symptomatic therapy can be given if considered necessary.

3

Special warnings

Frequent and repeated use of antiparasiticides from the same class may increase risk of development of resistance.

3

Withdrawal period

Meat and offal: 8 days.

Not to be administered to animals producing milk for human consumption including non-lactating ewes in the dry period.

3

Incompatibilities

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

3

Immediate packaging

The veterinary medicinal product is provided in white high-density polyethylene Carrick Flat Bottom Containers with polypropylene closures and induction heat-sealed wadding, at 1 litre, 2.5 litre and 5 litre pack sizes.

Not all pack sizes may be marketed.

3

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.

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 Years. Shelf life after first opening of the immediate packaging: 3 months.

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

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

The veterinary medicinal product should not enter water courses as cypermethrin may be dangerous for fish and other aquatic organisms.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

3

Additional information

Vm 50146/4019

8 DATE OF FIRST AUTHORISATION

10 December 2014

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

June 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 18 August 2025

3

Registration holder

Bimeda Animal Health Limited

3