SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF VETERINARY MEDICINAL PRODUCT

Ectofly 12.5 mg/ml Pour-on Solution for Sheep

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains

Active Substance

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

Excipients

Green S Dye (E142) 0.2 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Pour-On Solution.

Clear blue non-aqueous solution.

4. CLINICAL PARTICULARS 4.1 Target Species

Sheep.

4.2 Indications for use, Specifying the Target Species

For the treatment and control of headflies, and treatment of tick infestation and biting lice. For the prevention and treatment of blowfly strike.

4.3 Contraindications

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

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

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

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

4.4 Special Warnings for Each Target Species

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

4.5 Special Precautions For Use

Special precautions for use in animals

Care must be taken not to apply the 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 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 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

This product is harmful if swallowed and may cause skin, eye or respiratory irritation. This product may also cause hypersensitivity reactions.

Avoid skin and/or eye contact.

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

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

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

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

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

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.

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

Do not eat, drink or smoke whilst using the 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.

Other precautions

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 (see section 5.3, ‘Environmental properties’). Given the risks to the environment the use of the product should be limited to one treatment per year per pasture.

Long term effects on dung insects caused by continuous or repeated use of pyrethroid ectoparasiticides cannot be excluded. Therefore repeated treatment of animals on the same pasture with a pyrethroid-containing product within a season should only be given in the absence of alternative treatments or approaches to maintain animal/flock health, as advised by a veterinarian.

4.6 Adverse Reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy or lactation

Pregnancy:

Can be used during pregnancy. Pregnant ewes must be handled with care.

4.8 Interaction with other medicinal products and other forms of interaction

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

4.9 Amounts to be administered and administration route

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked. On completion of each treatment cycle of the product and before the dosing gun is stored, immediately expel any remaining product in the dosing gun.

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 PRODUCT WILL PREVENT BLOWFLY STRIKE ONLY ON AREAS COVERED 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 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. 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 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 dye to aid in the identification of treated animals. The colour is temporary and will fade from the fleece within 48 hours of application. 4.10 Overdose (symptoms, emergency procedure, antidotes), if necessary

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.

4.11 Withdrawal Periods

Meat and offal: 8 days.

Milk: 5 days

5. PHARMACOLOGICAL PROPERTIES

ATCvet code: QP53AC08

Pharmacotherapeutic group: ectoparasiticides for topical use, incl. Insecticides.

5.1 Pharmacodynamic Properties

Cypermethrin is a neuropoison acting on the axons in the peripheral and central nervous system 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.

Environmental Properties

Cypermethrin is moderately persistent and non-mobile in soil. It is extremely toxic to aquatic invertebrates. Cypermethrin is toxic to dung insects and to honey bees. Long term effects on dung insects caused by continuous or repeated use of the product cannot be excluded.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients Green S Dye (E142)

Diethylene glycol monobutyl ether

6.2 Major Incompatibilities

None known.

6.3 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.

6.4 Special Precautions for Storage

Do not store above 25°C.

Protect from direct sunlight.

Store in tightly closed original container in a safe place. Store away from food, drink and animal feeding stuffs.

6.5 Nature and Composition of Immediate Packaging

White high-density polyethylene flat bottom containers with polypropylene closures and induction heat-sealed wadding, at 1 litre, 2.5 litre 5 litre and 7.5 litre (2.5 litre + 5 litre) pack sizes.

Not all pack sizes may be marketed.

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

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 aquatic invertebrates. Do not contaminate ponds, waterways or ditches with the product or empty container.

7. MARKETING AUTHORISATION HOLDER

Bimeda Animal Health Limited

2 / 3 / 4 Airton Close

Tallaght

Dublin 24

Ireland

8. MARKETING AUTHORISATION NUMBER

Vm 50146/4017

9. DATE OF FIRST AUTHORISATION

5 April 2011

10. DATE OF REVISION OF THE TEXT

October 2018

Approved: 19 October 2018