Dectospot is licensed as a topical application for the control of lice and flies on cattle; for ticks, lice, keds and established blowfly strike on sheep and for lice and ticks on lambs.
On Cattle: for the control of both sucking and biting lice, including Damalinia bovis, Solenopotes capillatus, Linognathus vituli and Haematopinus eurysternus on all ages of cattle including dairy cattle producing milk for human consumption. Also as an aid in the control of both biting and nuisance flies including Haematobia irritans, Stomoxys calcitrans, Musca species and Hydrotaea irritans.
On sheep: For the control of ticks (Ixodes ricinus) and of lice and keds and established blowfly strike.
On lambs: For the control of ticks Ixodes ricinus and lice (Bovicola ovis).).
PRESENTATION
Spot-on solution
A clear pale gold oily liquid
TARGET SPECIES
Cattle and sheep.
CONTRA-INDICATIONS
None
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid inaccurate dosing, misadministration or too frequent and repeated use of ectoparasiticides from the same class over an extended period of time, as these practices increase the risk of development of resistance and could ultimately result in ineffective therapy.
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For external use only.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS
Wear protective clothing including a waterproof apron and boots and impervious gloves when either applying the product or handling recently treated animals.
Remove heavily contaminated clothing immediately and wash before use.
Wash splashes from skin immediately with soap and plenty of water.
Wash hands and exposed skin after handling this product and before meals.
In case of contact with eyes, rinse immediately with plenty of clean, running water and seek medical advice.
In case of accidental ingestion, wash out mouth immediately with plenty of water and seek medical advice.
Do not smoke, drink or eat while handling the product.
This product contains deltamethrin which may produce tingling, itchiness and blotchy redness on exposed skin. If you feel unwell after working with this product, consult your doctor and show this data sheet.
Advice to medical practitioners: Advice on clinical management is available from the National Poisons Information Service.
OTHER PRECAUTIONS
Deltamethrin is very toxic to dung fauna, aquatic organisms and honey bees. It is persistent in
Dectospot 05/07/16
soils and may accumulate in sediments. The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of deltamethrin (and other synthetic pyrethroids) in cattle and sheep, e.g. by using only a single treatment per year on the same pasture. The risk to aquatic ecosystems will be further reduced by preventing treated sheep from entering watercourses for one hour immediately after treatment.
ADVERSE REACTIONS (FREQUENCY & SERIOUSNESS)
Minor signs of discomfort have been seen in some cattle during the 48 hours after treatment. This is of no long term detriment to the animal.
USE DURING PREGNANCY AND LACTATION
Use only according to a benefit/risk assessment by the responsible veterinarian.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION:
Do not mix any other insecticide or acaricide with Dectospot Spot-on Solution.
AMOUNTS TO BE ADMINISTERED & ADMINISTRATION ROUTE
The product should be applied using an appropriate application device:
For the 250ml and 500ml presentation, a graduated chamber attached to the container is used.
For the 1 litre and 2.5 litre presentations it is recommended to use an appropriate applicator.
DOSE
Cattle: 10 ml
Sheep: 5ml
Lambs (under 10 kg bodyweight or 1 month of age): 2.5ml
ADMINISTRATION
Apply a single dose with the special dispenser pack or the Dectospot Applicator on one spot on the mid-line of the back at the shoulders, as directed on dispenser or applicator gun pack.
Lice on cattle: One application will generally eradicate all lice within 4 - 5 weeks during which time lice hatch from the eggs and are killed. It may be necessary on rare occasions to re-treat an animal 6 - 8 weeks later.
Flies on cattle: Good control can be expected for 4 - 8 weeks where horn flies dominate. Treatment for fly control should not be repeated within four weeks.
Ticks on sheep and lambs: Application will control ticks for up to 6 weeks after treatment.
Keds and lice on sheep and lice on lambs: Application will reduce the incidence of a biting louse or ked infestation over a 4 - 6 week period after treatment.
N.B. For control of ticks, keds and lice on sheep, the fleece should be parted and the spot on applied to the skin of the animal. When using the Dectospot applicator, application to the skin can be achieved by inserting the T bar to separate the fleece and penetrate down to the skin level before squeezing the applicator handle.
Apply directly to the maggot-infected area as WITHDRAWAL PERIODS
Cattle (meat) – 17 days
Cattle (milk) – zero hours
Sheep (meat) – 35 days This product is not authorised for use in ewes producing milk for human consumption.
PHARMACOLOGICAL PROPERTIES
ENVIRONMENTAL PROPERTIES
Deltamethrin has the potential to adversely affect non-target organisms, both in water and in dung. Following treatment, excretion of potentially toxic levels of deltamethrin may take place over a period of 2 to 4 weeks. Faeces containing deltamethrin excreted onto pasture by treated animals may reduce the abundance of dung-feeding organisms which may impact on the dung degradation.
Deltamethrin is very toxic to dung fauna, aquatic organisms and honey bees, is persistent in soils and may accumulate in sediments.
PHARMACEUTICAL PARTICULARS
List of excipients:
Triglycerides, medium chain
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: 2 years. Shelf-life after first opening the immediate packaging: 3 months
SPECIAL PRECAUTIONS FOR STORAGE
The veterinary medicinal product does not require any special temperature storage conditions. Keep the container in the outer carton in order to protect from light. Store in tightly closed original container away from food, drink and animal feeding stuffs. Keep the vial in the outer carton in order to protect from light
PACK SIZES
250ml, 500ml, 1 litre and 2.5 litre.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIAL DERVIED FROM THE USE OF SUCH PRODUCTS
Dangerous to fish and other aquatic life. Do not contaminate ponds, waterways or ditches with the product or used container Any unused veterinary medicinal product or waste materialsderived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dectospot 10 mg/ml Pour-on Solution for Cattle and Sheep
Each ml contains
Active Substance:
Deltamethrin 10.0 mg
For the full list of excipients, see section 6.1.
Pour-on Solution
A clear pale gold oily liquid
4.1 Target Species
Cattle and sheep.
Prevention and treatment of infestations by the following external parasites:
On cattle: For the treatment and prevention of infestations by both sucking and biting lice, including Bovicola bovis, Solenopotes capillatus, Linognathus vituli and Haematopinus eurysternus. Also as an aid in the treatment and prevention of infestations by both biting and nuisance flies including Haematobia irritans, Stomoxys calcitrans, Musca species and Hydrotaea irritans.
On sheep: For the treatment and prevention of infestations by ticks Ixodes ricinus and by lice (Linognathus ovillus, Bovicola ovis), keds (Melophagus ovinus) and established blowfly strike (usually Lucilia spp.).
On lambs: For the treatment and prevention of infestations by ticks Ixodes ricinus and by lice Bovicola ovis.
Do not use on convalescent or sick animals.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Extra-label use of the product in the non-target species dogs and cats can lead to toxic neurological signs (ataxia, convulsions, tremors), digestive signs (hypersalivation, vomiting) and may be fatal. Do not use in animals with extensive lesions of the skin.
The product will reduce the number of flies resting directly on the animal but it is not expected to eliminate all flies on a farm. Resistance to deltamethrin has been recognised and therefore the strategic use of the product should be based on local and regional epidemiological information about susceptibility of parasites, and used in association with other pest management methods.
Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
too frequent and repeated use of ectoparasiticides from the same class over an extended period of time; underdosing which may be due to underestimation of bodyweight, misadministration of the product or lack of calibration of the dosing device.
Cases of resistance to deltamethrin have been reported in stinging and nuisance flies in cattle and lice in sheep. To avoid resistance, the product should only be used if the susceptibility of the local fly population to the active substance is assured.
The product is for external use only.
Avoid contact with eyes and mucous membranes as Deltamethrin is an irritant.
Care should be taken to prevent animals grooming after administration of the product. Avoid use of the product during extremely hot weather and ensure animals have adequate access to water.
The product should only be administered onto undamaged skin as toxicity is possible due to absorption from major skin lesions. However, signs of local irritation may occur after treatment as skin may be already affected by infestation. Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to any component should avoid contact with the veterinary medicinal product. Personal protective equipment consisting of waterproof apron and boots and impervious gloves should be worn when either applying the product or handling recently treated animals.
Remove heavily contaminated clothing immediately and wash before re-use.
Wash splashes from skin immediately with soap and plenty of water.
Wash hands and exposed skin after handling this product.
In case of contact with eyes, rinse immediately with plenty of clean, running water and seek medical advice. In case of accidental ingestion, wash out mouth immediately with plenty of water and seek medical advice and show the package leaflet or the label to the physician.
Do not smoke, drink or eat while handling the product.
This product contains deltamethrin which may produce tingling, itchiness and blotchy redness on exposed skin. If you feel unwell after working with this product, seek medical advice immediately and show the package leaflet or the label to the physician.
Deltamethrin is very toxic to dung, fauna, aquatic organisms and honey bees, is persistent in soils and may accumulate in sediments.
The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of deltamethrin (and other synthetic pyrethroids) in cattle and sheep, e.g. by using only a single treatment per year on the same pasture.
The risk to aquatic ecosystems will be further reduced by preventing treated sheep from entering watercourses for one hour immediately after treatment.
In very rare cases, neurological signs (general agitation or prostration, tremors, abnormal movements), and/or skin disorders (squamosis and pruritus) have been observed within 48 hours after treatment. 4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects. Use only according to a benefit/risk assessment by the responsible veterinarian.
Do not use with any other insecticide or acaricide.
The toxicity of deltamethrin is enhanced in combination with organophosphorous compounds, in particular.
Pour-on Use.
Dose:
Cattle: 100 mg of deltamethrin per animal, corresponding to 10 ml of the product. Sheep: 50 mg of deltamethrin per animal, corresponding to 5 ml of product.
The product must be applied without dilution between the shoulder blades of the animal along the mid-line of the back.
For treatment and prevention of infestations by ticks, keds and lice on sheep, the fleece should be parted and the product applied to the skin of the animal. For maximum effectiveness it is advisable to:
treat shortly after shearing (animals with short fleece),
keep treated sheep separated from untreated sheep to avoid re-infestation
The duration of protection against flies is maintained for 4–6 weeks.
Lice on cattle: One application will generally eradicate all lice. Complete clearance of all lice may take 4 - 5 weeks during which time lice hatch from the eggs and are killed. A very few lice may survive on a small minority of animals.
Keds and lice on sheep: One application will reduce the incidence of a biting louse or ked infestation over a 4 - 6 week period after treatment.
The influence of weather on the duration of efficacy has not been investigated. The duration of the prevention period against Musca spp. may vary.
The product should be applied using an appropriate application device:
An appropriate applicator should comply with the following specifications :
The recommended use of the application devices is illustrated on the following diagrams.
Some adverse effects have been seen following overdose. These include paraesthesia and irritation in cattle, as well as intermittent or attempted urination in young lambs. These have been shown to be mild, transient and resolve without treatment.
Cattle
Meat and offal – 18 days
Milk – zero hours
Sheep
Meat and offal – 35 days
Milk – 24 hours
Due to the significant likelihood of cross-contamination of non-treated animals with this product due to grooming (licking), treated animals should be kept separately from non-treated animals throughout the maximum withdrawal period. Non-compliance with this recommendation may lead to residues in non-treated animals.
ATCvet code: QP53AC11
Pharmacotherapeutic group: Ectoparasiticides, insecticides and repellents. Pyrethrins and pyrethroids.
The deltamethrin molecule belongs to the family of synthetic pyrethroids. It is characterized by its insecticidal and acaricidal activity, acting by altering the permeability of the sodium channel molecule causing hyperarousal, followed by paralysis (knockdown), with tremors and mortality of parasites. Two physiological mechanisms are likely to contribute to deltamethrin-resistance: mutation of the molecular deltamethrin target or genomic selection for increased expression of mitochondrial oxidase and esterase enzymes.
After dermal application, deltamethrin is slightly absorbed through skin of cattle and sheep.
Pyrethroids are metabolised through oxidative and neurotoxic pathways.
The main route of excretion of the absorbed amount in the target animal is the faeces.
Deltamethrin has the potential to adversely affect non-target organisms, both in water and in dung. Following treatment, excretion of potentially toxic levels of deltamethrin may take place over a period of 4 weeks Faeces containing deltamethrin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Deltamethrin is very toxic to dung fauna, aquatic organisms and honey bees, is persistent in soils and may accumulate in sediments.
6.1 List of excipients
Triglycerides, medium chain
6.2 Incompatibilities
None known.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: 3 months.
Store upright in the original container.
Keep the container in the outer carton in order to protect from light. Keep away from food, drink and animal feeding stuffs.
250 ml and 500 ml high density polyethylene flexipacks with twin neck dispenser, internal graduated calibration chamber and polypropylene heat-sealed screw cap.
1 litre and 2.5 litre high-density polyethylene flat bottom containers with polypropylene closures and induction heatsealed wadding. A spouted cap is provided with the 1 litre and 2.5 litre presentations.
Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
The product should not enter water courses as this may be dangerous for fish and other aquatic organisms. Do not contaminate surface waters or ditches with the product or used container. Deltamethrin has been shown to be persistent in soil.
Cross Vetpharm Group Ltd
Broomhill Road
Tallaght
Dublin 24
VPA 10960/083/001
Date of first authorisation: 12th February 2016
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