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Date: Thursday, June 13, 2024 16:39

Description: Bimeda logo
Release 5.45
Ectofly 12.5 mg/ml Pour-On Solution for Sheep
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For sheep
Active ingredient: Cypermethrin
Product:Ectofly 12.5 mg/ml Pour-On Solution for Sheep
Product index: Ectofly 12.5 mg/ml Pour-On Solution for Sheep
Sheep - meat: 8 days
Withdrawal notes: Sheep Milk- 5 days
Incorporating:
Qualitative and quantitative composition
Each ml contains
Active Substance:
Cypermethrin High:Cis (80:20) 12.5 mg
Pharmaceutical form
Clear, blue, non-aqueous pour-on solution.
Clinical particulars
Target species
Sheep.
Indications for use
For the treatment and control of headflies, and treatment of ticks and biting lice. For the prevention and treatment of blowfly strike.
Contra-indications
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.
Special warnings for target species
Frequent and repeated use of antiparasiticides from the same class may increase the risk of development to resistance.
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 more 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 dagged (crutched) 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 applicator gun. Please read carefully before use. Maintain applicator 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 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
Adverse reactions
None known.
Use during pregnancy or lactation
Can be used during pregnancy. Pregnant ewes must be handled with care. See section 'Withdrawal Periods'.
Interactions
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.
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:
Blowfly Prevention Fan Spray Dose Using Blue Fan Spray Nozzle (FIGURE 1 BELOW)
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 applicator gun fitted with the blue 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.
FIGURE 1
Description: h-828
Treatment of blowfly strike
Apply directly to all the affected parts at the rate of 2.5 ml per 100 –150 cm2 . The Red 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:
SEE FIGURE 2 Below
Dosage: 5 ml per 20 kg bodyweight up to a maximum of 20 ml.
Lice
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 green 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.
FIG. 2Description: h-823
Ticks:
SEE FIGURE 3 Below
Dosage: 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.
Ticks
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 green straight nozzle on the Pour-On Gun, apply as a pin-stream from the crown of the head to the top of the rump.
FIG. 3Description: h-824
Headflies
See FIGURE 4 Below
Dose: 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.
FIG. 4Description: h-825
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.
Overdose
Toxic signs in mammals are tremors, hyperexcitability, salivation, choreoathetosis 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.
Withdrawal periods
Meat and offal: 8 days.
Milk: 5 days
Pharmacological particulars
Pharmacotherapeutic group: ectoparasiticides for topical use, incl. Insecticides. ATC vet code: QP53AC08.
Pharmacodynamic properties
Cypermethrin is a neuropoison acting on the axons in the peripheral and central nervous system of insects by interacting with sodium channels.
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.
Pharmaceutical particulars
List of Excipients
Green S Dye (E142)
Diethylene glycol monobutyl ether
Major incompatibilities
None known.
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.
Special precautions for storage:Store away from food, drink and animal feeding stuffs.
Do not store above 25°C. Protect from direct sunlight. Store in tightly closed original container.
Immediate packaging
White high-density polyethylene flat bottom containers with polypropylene closures and induction heat-sealed wadding, at 2.5 litre and 5 litre pack sizes.
Not all pack sizes may be marketed.
Disposal
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.
Marketing Authorisation Number
Vm 50146/4017
Significant changes
Date of the first authorisation or date of renewal
5 April 2011
Date of revision of the text
October 2018
Any other information
Nil
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Ectofly 2.5L
GTIN:5391510233107
GTIN description:Ectofly 5L
GTIN:5391510232995