Ectofly, containing 1.25% cypermethrin, is convenient pour on for the control and treatment of a broad range of sheep ecto-parasites.
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ectofly 12.5 mg/ml Pour-On Solution for Sheep
Each ml contains
Active Substance
Cypermethrin tech. (cis:trans / 80:20) 12.5 mg
Green S Dye (E142) 0.2 mg
For the full list of excipients, see section 6.1.
Pour-On Solution.
Clear blue non-aqueous solution.
4.1 Target Species
Sheep.
For the treatment and control of headflies, and treatment of tick infestation and biting lice. For the prevention and treatment of blowfly strike.
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.
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.
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.
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.
Pregnancy:
Can be used during pregnancy. Pregnant ewes must be handled with care.
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.
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:
|
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.
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.
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.
Meat and offal: 8 days.
Milk: 5 days
ATCvet code: QP53AC08
Pharmacotherapeutic group: ectoparasiticides for topical use, incl. Insecticides.
Cypermethrin is a neuropoison acting on the axons in the peripheral and central nervous system of insects by interacting with sodium channels.
Synthetic pyrethroids are generally metabolised in mammals through ester hydrolysis, oxidation and conjugation and there is no tendency to accumulate in tissues.
5.3 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.
Green S Dye (E142)
Diethylene glycol monobutyl ether
6.2 Incompatibilities
None known.
|
Shelf life of the veterinary medicinal product as packaged for sale: |
2 Years. |
|
Shelf life after first opening of the immediate packaging: |
3 months. |
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.
White high-density polyethylene 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.
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.
Cross Vetpharm Group Ltd.
Broomhill Road
Tallaght
Dublin 24
Ireland
8 MARKETING AUTHORISATION NUMBER(S)
VPA 10960/075/001
Date of first authorisation: 20th April 2012
Date of last renewal: 30th September 2016
Menu
