A pale yellow, clear, water miscible micro emulsion concentrate containing cypermethrin (cis/trans 80/20) 10% w/w, for dilution with water before use.
USES
For the prevention and treatment of blowfly strike, lice, keds and ticks on sheep by plunge dipping after dilution of the product with water. For the prevention and treatment of sheep scab caused by pyrethroid sensitive mites.
DOSAGE AND ADMINISTRATION
For blowfly, keds, ticks, lice and sheep scab.
Initial dilution rate: 1 litre of dip to 500 litres water Replenishment: 1 litre of dip to 500 litres water. Do not dilute the product until it is actually required.
To Prepare the Bath
Baths should be accurately calibrated. Fill the bath with the required quantity of clean water. Pour the required measured volume of dip directly into the bath to give the required strength at a rate of 2 Litres of Cyperguard per 1000 litres (220 gallons) of water.
Stir the bath thoroughly from end to end to ensure complete mixing.
Replenishment
Replenish after every 50 sheep dipped. The bath should be topped up to its original volume with water. Then add 20ml of dip concentrate for each 10 Litres of water added.
Dipping
For Blowfly, Tick, Lice and Keds. Immerse the sheep in the bath until the fleece is completely saturated with dip wash. All parts of the sheep except the head and ears must remain immersed for not less than thirty seconds. Plunge the head under at least twice, allowing time to breathe between plunges. To reduce the risk of Blowfly strike, control worms and treat all wounds. Skim off at regular intervals any scum which may form on the surface of the dipping bath.
Blowfly
A single treatment will provide up to 9 weeks control of Blowfly strike. Occasionally retreatment may be necessary after 4 to 9 weeks depending on the level of challenge, weather conditions, and timing of the first dipping.
Sheep Scab, Its Cure and Prevention
For the purposes of dipping against sheep scab, sheep must be totally immersed in a sheep bath of an approved sheep dip, and all parts of the sheep except the head and ears must remain immersed in the bath for a period which shall in no case be less than one minute. Plunge the head under at least once.
To Prevent Fouling of the Bath It is important that the dip bath is emptied and thoroughly clean at the end of each days dipping or earlier if it becomes very dirty during the days dipping. Dip no more than one sheep for every 2 litres of the initial bath volume before the bath is completely emptied.
CONTRA-INDICATIONS, WARNINGS ETC.
Sheep should never be dipped on a full stomach, when the wool is wet, or when they are heated, tired, thirsty or suffering from wounds or open sores. Do not use where there is known hypersensitivity to the active ingredient. For best results sheep should not be dipped soon after shearing, but should have at least 3 weeks growth of wool. Choose a cool, dry day and dip early in the morning. Rest sheep 2 or 3 hours before dipping. Rams and fat sheep should be assisted through the bath and lambs dipped separately from the ewes. Care should be taken
Date data sheet created: January 2016
an enclosed building. Do not dilute the product until it is actually required.
WITHHOLDING PERIODS
Following treatment with Cyperguard Sheep Dip, sheep may not be slaughtered for human consumption for 14 days. Animals must not be slaughtered for human consumption during treatment. The product must not be used on sheep producing milk for human consumption.
To Avoid Post Dipping Lameness
Post dipping lameness may occur when the sheep are dipped in dirty wash, or wash which has been allowed to stand in the bath overnight
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyperguard Concentrate for Dip Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance:
Cypermethrin High Cis (80/20) 10 %w/w
Excipients:
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for Dip Emulsion
This product appears as a clear, pale yellow liquid.
4 CLINICAL PARTICULARS
4.1 Target Species
Sheep
4.2 Indications for use, specifying the target species
For the prevention and treatment of blowfly strike, lice, keds and ticks on sheep by plunge dipping after dilution of the product with water. For the prevention and treatment of sheep scab caused by pyrethroid sensitive mites.
4.3 Contraindications
Do not use in cases of known hypersensitivity to the active ingredient.
4.4 Special warnings for each target species
Sheep should never be dipped on a full stomach, when the wool is wet or when they are heated, tired, thirsty or suffering from wounds or open sores.
Choose a cool dry day and dip early in the morning.
Rest sheep 2 or 3 hours before dipping.
Rams and fat sheep should be assisted through the baths and lambs dipped separately from the ewes.
Care should be taken to ensure that the sheep do not swallow or inhale any wash.
To avoid Post Dipping Lameness
Post dipping lameness may occur when the sheep are dipped in dirty wash, or wash which has been allowed to stand in the bath overnight or longer. It is important that the dip bath should be emptied and thoroughly cleaned at the end of each day’s dipping or earlier if it becomes very dirty during the day’s dipping.
4.5 Special precautions for use
Special precaution(s) for use in animals
After dipping, sheep should be allowed to stand in a bare open space under shade if possible but never in an enclosed building. For best results sheep should not be dipped soon after shearing but should have at least 3 weeks growth of wool.
Animals should not be dipped when they are heated, tired or thirsty.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Minimise operator contamination by good dipping facility design, e.g. fit splash boards where operators stand. Ensure that those using dips are competent to do so.
When handling concentrate including dip replenishment:
Do not use in an enclosed area and avoid inhaling vapour.
Wear non-lined, synthetic rubber gloves (heavy-duty gauntlet style nitrile at least 300mm in length and 0.5mm thick), wellington boots, waterproof (made of nitrile of PVC) trousers or leggings and coat or bib apron and a face shield when handling the concentrate.
Wash splashes of the dip concentrate from skin and eyes and from protective clothing and equipment immediately.
Remove heavily contaminated clothing immediately and wash or destroy.
When working with diluted dips and freshly dipped sheep:
Dipping should only be carried out in a well ventilated area, preferably outdoors.
Wear non-lined, synthetic rubber gloves (heavy-duty gauntlet style nitrile at least 300mm in length and 0.5mm thick), wellington boots, waterproof (made of nitrile of PVC) trousers or leggings and coat or bib apron.
Accidental splashes on exposed skin should be washed off immediately. Wash hands, face and exposed skin immediately after leaving the work area, removing protective clothing and washing hands, face and exposed skin.
Do not smoke, drink or eat during dipping without first withdrawing from the work area, removing protective clothing and washing hands, face and exposed skin.
Remove heavily contaminated clothing immediately and wash or destroy.
Check and replace any worn or damaged items of protective clothing. Wash measuring and dipping equipment after use. Protective clothing should be washed each day after dipping operations to prevent build up of chemicals in the materials.
Handling sheep in the weeks following dipping:
Handle sheep as little as possible after dipping as dip residues remain on the sheep for some weeks following dipping.
If you need to handle sheep, wear coveralls and wellington boots. If the sheep are wet, wear waterproof trousers and coat or bib-apron and wellington boots.
Always wash hands and exposed skin with soap and water after handling sheep or fleece and before eating, drinking and smoking.
Medical Advice to users and doctors:
Please note that Cyperguard is a non-organophosphorus sheep dip.
This product contains cypermethrin which is a synthetic pyrethroid. Cypermethrin is a potential skin sensitiser and may induce paraesthesia or tingling effects on exposed areas of human skin.
Wash all accidental spillages of the concentrate and diluted dip off the skin immediately. If you feel unwell after working with this product consult your doctor and show this label.
Doctors can obtain advice on clinical management from the Poisons Information Centre.
Harmful if in contact with skin and if swallowed. Irritating to eyes and skin.
4.6 Adverse reactions (frequency and seriousness)
Post dipping lameness may occur when sheep are dipped in dirty wash or wash that has been allowed to stand overnight.
4.7 Use during pregnancy, lactation or lay
No data are available to support the safe use in pregnant or lactating animals.
4.8 Interaction with other medicinal products and other forms of interaction
It is not anticipated that Cyperguard will interact with any of the medicines commonly administered to sheep.
4.9 Amounts to be administered and administration route
(1) For Blowfly, Keds, Lice and Ticks
Initial Dilution Rate: 1 in 500 Replenishment: 1 in 500
(2) For Sheep Scab
Initial Dilution Rate: 1 in 500 Replenishment: 1 in 500
A single treatment will provide up to 9 weeks control of Blowfly Strike. Occasionally retreatment may be necessary after 4-9 weeks depending on the level of challenge, weather conditions and the timing of the first dipping.
Do not dilute the product until it is actually required.
To prepare the bath: Baths should be accurately calibrated. Fill the bath with the required quantity of clean water. Pour the required measured volume of dip directly into the bath to give the required strength. Stir the bath thoroughly from end to end to ensure complete mixing.
Replenishment: replenish after every 50 sheep dipped. The bath should be topped up to its original volume with water. Then add 20 ml of dip concentrate for each 10 litres of water added.
Dipping: Blowfly, Keds, Lice and Ticks: Immerse the sheep in the bath until the fleece is completely saturated with dip wash. All parts of the sheep except the head and ears must remain immersed for not less than thirty seconds. Plunge the head under at least twice, allowing time to breathe between plunges. To reduce the risk of Blowfly strike, control worms and treat all wounds.
Skim off at regular intervals any scum which may form on the surface of the dipping bath.
Sheep Scab: Cure and Prevention: For the purposes of dipping against sheep scab, sheep must be totally immersed in a sheep bath of an approved sheep dip, and all parts of the sheep except the head and ears must remain immersed in the bath for a period which shall in no case be less than one minute. Plunge the head under at least once.
To prevent fouling of the bath: It is important that the dip bath is emptied and thoroughly cleaned at the end of each day’s dipping or earlier if it becomes very dirty during the days dipping. Dip no more that one sheep for every 2 litres of the initial bath volume before the bath is completely emptied.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Tolerance studies at 2.5 times the recommended dosage rate indicated excellent tolerance by the target species.
Care should be taken not to overdose. Overdosing may invalidate the stated meat withholding times.
In the case of overdosing, treatment should be symptomatic.
4.11 Withdrawal Period(s)
Animals must not be slaughtered for human consumption during treatment.
Meat and offal: 14 days.
Not for use in sheep producing milk for human consumption.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Ectoparasiticides for topical use, Pyrethrins and pyrethoids ATCvet Code: QP53AC08
5.1 Pharmacodynamic properties
Cypermethrin is a synthetic pyrethroid insecticide used for both crop protection and to control ectoparasites on livestock.
Cypermethrin is a contact poison, having a rapid paralytic action on insects, preceded by muscular excitations and convulsions. The pyrethroids have sufficient prolonged stability on the animal to have a knockdown and kill effect on insects.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
N-methyl 2 pyrrolidone
N-octyl 2 pyrrolidone
Ethoxylated Castor Oil Pluronic L131
Rhodafac RS 710
6.2 Incompatibilities
Do not mix the product with other medicinal product.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. Any unused diluted product should be discarded after the day's dipping.
6.4 Special precautions for storage
Store below 25oC. Protect from light.
Store in the original container. Keep the container tightly closed.
6.5 Nature and composition of immediate packaging
Multilayered plastic containers with an internal polyamide layer in 1 L, 2 L and 5 L sizes. The containers are sealed with a tamper evident polyethylene screw-cap which has a tear off locking flange.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Dangerous to fish and other aquatic life.
Do not contaminate water including ponds, ditches, ground and surface waters. It is an offence to permit any poisonous, noxious or polluting matter to enter any river, stream or watercourse.
In order to protect aquatic life, it is important to ensure that sheep have an area where they can dip from the fleece and drain back into the bath immediately after dipping and also to ensure that sheep do not enter or cross watercourses whilst the fleece is still wet. Do not dip sheep near a watercourse.
Empty containers should not be re-used. Wash out thoroughly and place rinsings into the dip bath. Dispose of containers by approved means.
Only buy sufficient product for immediate use. Do not dispose of the dip concentrate on the farm. Any undiluted product should be disposed of by a reputable specialist waste disposal contractor.
The spent dip wash should be disposed of by a reputable waste disposal contractor. If you have a suitable area of land, you may apply not more than 5000 litres of used dip per hectare (450 gallons/acre).
7 MARKETING AUTHORISATION HOLDER
Cross Vetpharm Group Ltd.,
Broomhill Road,
Tallaght,
Dublin 24.
MARKETING AUTHORISATION NUMBER(S)
VPA 10960/031/001
DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14th May 2008
10 DATE OF REVISION OF THE TEXT
16th November 2009
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