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Date: Thursday, June 13, 2024 18:10

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.52
CLiK Extra 65 mg/ml Pour-On Suspension for Sheep
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For sheep
Active ingredient: Dicyclanil
Product:CLiK Extra 65 mg/ml Pour-On Suspension for Sheep
Product index: CLiK Extra 65 mg/ml Pour-On Suspension for Sheep
Sheep - meat: 40 days
Withdrawal notes: Not authorised for use in animals producing milk for human consumption.
Incorporating:
Qualitative and quantitative composition
Each ml contains:
Active substance: Dicyclanil 65 mg
Excipients:
Methyl parahydroxybenzoate (E218) 1.50 mg
Propyl parahydroxybenzoate 3.00 mg
Butylated hydroxytoluene 0.50 mg
Ponceau 4R 0.05 mg
For the full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Pour-on Suspension
Pink coloured suspension
Clinical particulars
Target Species
Sheep
Indications for use, specifying the target species
Prevention of blowfly strike on sheep caused by Lucilia sericata or Wohlfahrtia magnifica.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
The veterinary medicinal 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 or crutched 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.
Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Redness and irritation may develop after skin or eye contact with the product.
Contact with skin and eyes should be avoided.
Personal protective equipment consisting of synthetic rubber gloves and PVC trousers should be worn when handling the 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 wash immediately with clean water.
Always wash hands and exposed skin with soap and water after work.
Do not eat, drink or smoke whilst using the product.
Residues remain on the fleece for some time after treatment, therefore, it is good agricultural practice to minimise handling of sheep after treatment. If you need to handle sheep within 3 months after treatment, wear synthetic rubber gloves and long trousers or coveralls. If sheep are wet wear waterproof trousers.
Do not shear sheep in the 3 months after treatment.
Other precautions
Treated sheep must be kept away from watercourses for at least one hour after treatment. There is a serious risk to aquatic life if this advice is not followed.
Other precautions
Not applicable.
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 according to the benefit/risk assessment by the responsible veterinarian.
Laboratory studies in rats and rabbits have not produced any evidence of 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:
Bodyweight (kg)
Dose Volume (ml)
10-20
20
21-30
24
31-50
30
>50
36
Guide dose volumes correspond to 0.6 – 2 ml [39 – 130 mg dicyclanil] per kg bodyweight.)
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.
If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing.
Recommended for treatment in sheep with any wool length, including off-shears. Shake the container well before use.
Do not dilute with water.
The veterinary medicinal product must be applied with a manual or automatic dosing gun, fitted 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 along the spine of the animal in bands 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.
Description: 4 Stroke Method Application Metric CLiK_2_
The veterinary medicinal product should be applied before, or at the start of, predicted fly activity.
The veterinary medicinal product will protect against fly strike for 19 weeks. It is good agricultural practice to check animals regularly for fly strike.
Overdose (symptoms, emergency procedures, antidotes), if necessary
An overdose of up to at least 4 times the recommended dose does not lead to any signs of local or systemic intolerance.
No antidote is known.
Withdrawal Period(s)
Meat and offal: 40 days
Not authorised for use in animals producing milk for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: Other ectoparasiticides for topical use. ATC vet code: QP53AX24.
Pharmacodynamic properties
Dicyclanil prevents the moult from the first to the second larval instar of Lucilia sericata and Wohlfahrtia magnfica. It is less effective against later larval stages and does not have any adulticidal action. The mode of action of dicyclanil is believed to be similar to that of the triazine compounds.
Pharmacokinetic properties
In studies with the 50 mg/ml formulation, after 7 days post dosing, approximately 5 % of the dose was absorbed and eliminated in urine and faeces. Peak blood levels were observed between 12 and 48 hours post dose, accounting for < 0.025 mg dicyclanil equivalents/kg.
In experimental metabolism studies, absorbed drug was widely distributed throughout the body. Longest half lives were found in liver and kidney being 13 and 10 days respectively. In muscle, fat and wool, unchanged dicyclanil was found to be the major residue, whereas in liver and kidney the descyclopropyl dicyclanil was found to be the major residue together with unchanged dicyclanil.
Environmental properties
Dicyclanil has the potential to cause harmful effects on aquatic invertebrates and dung fly larvae.
Following use of this product, levels of dicyclanil potentially harmful to dung fly larvae have been shown to be excreted in faeces for approximately 4 weeks. Faeces from treated animals may temporarily reduce the abundance of dung fly larvae which may impact on dung degradation.
Pharmaceutical particulars
List of excipients
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate
Butylated hydroxytoluene
Ponceau 4R
Polysorbate 20
Acrylic acid copolymer
Disodium edetate
Distilled monoglycerides
Triglycerides, medium-chain
Propylene glycol
Sodium hydroxide
Purified water
Major Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the immediate packaging: 1 year
Special precautions for storage
Store in the original container.
Keep the container tightly closed, away from food, drink and animal feedstuffs.
Protect from direct sunlight.
Protect from frost
Nature and composition of immediate packaging
1 L, 2.5 L and 5 L white opaque polyethylene back pack containers filled with 0.8 L, 2.2 L and 5 L, respectively, and closed with a polypropylene screw cap.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products or waste materials
Medicines should not be disposed of via wastewater.
The product should not enter water courses as dicyclanil may be dangerous for fish and other aquatic organisms.
Do not contaminate ponds or other waterways with product or empty containers.
Ask your veterinary surgeon on pharmacist how to dispose of medicines no longer required.
For IE only: 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.
For UK (GB) and UK (NI) only: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. These measures should help to protect the environment.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
UK (Great Britain): Vm 00879/5013
UK (Northern Ireland): Vm 00879/3010
Significant changes
Date of the first authorisation or date of renewal
21 October 2016
Date of revision of the text
April 2023
Any other information
Legal category
Legal category: POM-VPS
GTIN
GTIN description:CLiK Extra 65 mg/ml Pour-On Suspension for Sheep 2.2 L
GTIN:05014602804565
GTIN description:CLiK Extra 65 mg/ml Pour-On Suspension for Sheep 5.0 L
GTIN:05014602804800