Target species
Sheep
Indications for use, specifying the target species
Prevention of blowfly strike due to Lucilia sericata on sheep.
Prevention of blowfly strike due to Wohlfahrtia magnifica on sheep.
Contraindications
Do not use in sheep producing milk for human consumption.
Do not use in case of hypersensitivity to the active substance or any of the excipients.
Special warnings for each target species
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each flock.
Special precautions for use
i) Special precautions for use in animals
The product is best applied before an anticipated blowfly challenge, or when a blowfly challenge is identified on or in the vicinity of the farm. Established strikes may require a separate treatment with a knockdown insecticide.
It is recommended that animals with dirty back-ends are dagged prior to application. If dagging or crutching is undertaken in the weeks following application, these animals should be re-treated, otherwise protection could be lost.
Do not apply during heavy rainfall, or when such conditions are expected. The resulting wash out may reduce the protection period.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
· Operators should wear synthetic rubber gloves, a face mask and PVC trousers when applying the veterinary medicinal product.
· In case of skin contact remove contaminated clothing and thoroughly wash the affected parts of the body with soap and water.
· In case of eye contact rinse eyes with clean water for several minutes and contact physician for advice.
· In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
· Always wash hands with soap and water after handling sheep and before eating and drinking or smoking.
· Wash hands and exposed skin after working with recently treated sheep.
· Do not eat, drink or smoke whilst using the veterinary medicinal product.
Handling sheep in the weeks following treatment:
∙ Do not shear sheep in the 3 months after treatment.
∙ Handle sheep as little as possible after treatment as residues remain on the fleece for some weeks.
∙ If you need to handle sheep after treatment, wear coveralls and Wellington boots. If sheep are wet also wear waterproof trousers and coat.
Special precautions for the protection of the environment:
The use of the veterinary medical product has harmful effects on dung flies. Treated sheep must be kept away from watercourses for at least one hour after treatment. There is serious risk to aquatic life if this advice is not followed.
iii). Other precautions
None.
Adverse reactions (frequency and seriousness)
Target species: Sheep.
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 the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian. Laboratory studies in rats and rabbits have not shown any evidence of a teratogenic, foetotoxic or maternotoxic effects.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
For external use only.
The veterinary medicinal product is applied according to the following recommendations:
Body weight (kg) | Dose Volume (ml) |
10-20 | 20 |
21-30 | 25 |
31-50 | 30 |
>50 | 35 |
(Guide dose volumes correspond to 0.6 – 2 ml (30 – 100 mg dicyclanil) per kg bodyweight.)
Shake the container well before use.
The veterinary medicinal product must be applied with a manual or automatic dosing gun (e.g. Elanco Pour-on gun), with a spray nozzle, which guarantees the correct spreading of the product on the fleece. Best results will be achieved by holding the gun approximately 45 cm from the sheep during application. Apply as a fan spray using a 4 stroke method as shown in the pictogram along the spine of the animal in a band at least 10 cm wide from the middle of the shoulders and in an arc around the crutch and tail. Half the dose should be applied along the spine with the remainder over the tail and crutch area.
The veterinary medicinal product is administered once, before predicted Wohlfahrtia fly activity, or before or at the beginning of Lucilia fly activity. The veterinary medicinal product will protect against blowfly strike caused by Wohlfahrtia or Lucilia flies for 16 weeks. In individual cases, a strike may occur earlier; therefore, it is good practice to check animals regularly for blowfly strike.
Do not shear sheep in the 3 months after treatment.
Overdose (symptoms, emergency procedures, antidotes), if necessary
An overdose of up to at least 5 times the recommended dose does not lead to any signs of local or systemic intolerance. An antidote is not known.
Withdrawal period(s)
Meat and offal: 40 days
Not authorised for use in animals producing milk for human consumption.