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Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Winter Dip Concentrate for dip emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Diazinon (Dimpylate) 10% w/v.
Excipients
Multisol H585 (hydrocarbon solvent) 75 % w/v
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for dip emulsion
A yellow/brown emulsifiable dip concentrate.
4 CLINICAL PARTICULARS
Diazinon
4.1 Target Species
Sheep
4.2 Indications for use, specifying the target species
For the treatment and control of sheep scab (Psoroptes ovis) and blowfly in sheep.
4.3 Contraindications
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
Do not use on sheep producing milk for human consumption.
4.4 Special warnings for each target species
None
4.5 Special precautions for use
Special precautions for use in animals
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 bath and lambs dipped separately from ewes.
Care should be taken to ensure that the sheep do not swallow or inhale any wash.
The dip should be freshly made and used only on the day of preparation.
Do not retain the dip wash for a second day’s dipping.
Prepare the bath and dip following detailed instructions.
Ensure the bath and water is clean before starting to dip.
This product does not contain a bacteriostat.
If the bath is allowed to become too fouled, bacterial infection could become a problem.
Monitor the sheep on the days following dipping and seek veterinary advice if necessary.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Diazinon is an organophosphorous compound.
Do not use this product if under medical advice not to work with organophosphorous compounds.
WINTER DIP MUST BE USED IN ACCORDANCE WITH THE DISPENSING INSTRUCTIONS PROVIDED USING THE HYGEIA CLOSED TRANSFER SYSTEM UNIT
It is essential that the advice on wearing protective clothing* is strictly adhered to at all times when handling sheep dip concentrate, when using the CTS dispensing unit and when washing used concentrate containers and the dispensing unit.
When Handling the Concentrate including Dip Replenishment :
Wear suitable protective clothing.
* Wash splashes of the dip concentrate from the skin and eyes and from protective clothing and equipment immediately.
Do not use in an enclosed area and do not inhale the vapour.
Remove and wash heavily contaminated clothing immediately.
When Working with Diluted Dips and Freshly Dipped Sheep Minimise operator contamination by good dipping facility design – e.g. fit splash boards where operators stand.
The product should only be used in a well ventilated area, preferably outdoors.
Avoid use in still-air conditions.
Wear suitable protective clothing*.
Wash hands, face and exposed skin after a break in dipping and at the end of the day.
Accidental splashes should be washed off immediately.
Do not smoke, drink or eat during dipping.
Remove and wash heavily contaminated clothing immediately.
Protective clothing should be washed each day after dipping operations to prevent build up of chemicals.
Wash all equipment after use.
*Suitable protective clothing consists of non-lined synthetic rubber gloves (heavy duty gauntlet style PVC or nitrile at least 0.3mm thick), wellington boots, waterproof trousers or leggings and waterproof coat or bib-apron (made of nitrile or PVC).
When handling the concentrate use a face shield.
Protective clothing should be in good condition.
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.
Wear recommended gloves.
If the sheep are wet, wear waterproof trousers and coat. Wash hands and exposed skin after working with recently dipped sheep.
Medical Advice to Users and Doctor Diazinon is an organophosphorus compound.
Do not use if under medical advice not to work with such compounds.
If you have felt unwell after using a product containing an organophosphorus compound, you should consult your doctor before working with this product.
Wash all accidental spillages of the concentrate off the skin immediately.
Cases of heavy contamination should be treated as an emergency and the patient taken straight to hospital after removing contaminated clothing and rinsing with water areas of skin that came in contact with sheep dip.
The symptoms of mild poisoning are a feeling of exhaustion and weakness that may be accompanied by cramp-like abdominal pains, diarrhoea, excessive sweating, constricted pupils and salivation to up to 24 hours after exposure. Severe poisoning can cause general muscle twitching and convulsions.
Doctors can obtain advice on clinical management from the Poisons Information Centre, Beaumont Hospital, Dublin.
All cases of organophosphorus poisoning must be treated in hospital.
4.6 Adverse reactions (frequency and seriousness)
There have been no reports of adverse reactions, including lack of efficacy, at any time.
4.7 Use during pregnancy, lactation or lay
The product may be used in pregnant and lactating animals.
4.8 Interaction with other medicinal products and other forms of interaction
Do not mix with or use with any other dip.
Do not combine with copper fungicides.
Not to be used with neuroleptic phenothiazine derivatives.
Organophosphorous compounds increase the toxicity of these compounds.
As this is an organophosphorous sheep dip, an interval of at least 14 days should elapse between dipping and dosing with any drench, etc., containing an organophosphorous compound.
4.9 Amounts to be administered and administration route
For cutaneous (topical) use.
Animals are treated by total immersion in the dip bath.
Winter Dip concentrate must only be dispensed using Hygeia Closed Transfer System (CTS) unit.
The unit must be calibrated prior to dispensing into the dip tank.
Read the instructions before using the CTS unit.
To prepare the bath:
Measure the required volume of cold water into the bath.
Then add the Dip by following the instructions provided with the dispensing kit for fitting it to the container of dip concentrate and for dispensing the dip concentrate safely to the bath in the proportion of - 2.25 litres (0.5 gallon) of dip concentrate [i.e. 9 x 250ml deliveries from the dispensing pump] to 900 litres (200 gallons) of water, equivalent to 250ppm of Diazinon.
Stir the bath thoroughly from end to end before commencing dipping and dip on the day the bath is prepared.
To dip the sheep: Immerse the sheep in the bath for a minimum of one minute.
Keep the sheep moving forward and crutch the head under at least once.
Care should be taken to see that they do not swallow or inhale the wash.
Dip baths of 2250 litres or less must be replenished every 36 sheep.
Dip baths over 2250 litres are replenished every 90 sheep
Replenish, as the levels fall, as directed hereunder.
This combined with a clean bath, will give best results.
If this recommendation is not observed, sheep passing through the bath at a low dip level (or a foul bath) will not be as effectively treated or protected as those passed through earlier.
To replenish the bath:
a) Baths less than 2250 litres (500 gallons): after every 36 sheep dipped, add 1 litre [i.e. 4 x 250ml deliveries from the dispensing pump] into the dip tank and sufficient water to restore the bath to its original volume.
b) Baths greater than 2250 litres (500 gallons). after every 90 sheep dipped , add 2.5 litres [i.e. 10 x 250ml deliveries from the dispensing pump] into the dip and sufficient water to restore the bath to its original volume.
When a bath becomes foul, always empty it and refill with fresh dip.
For the purposes of the control of sheep scab, sheep must be totally immersed in a bath and all parts of the sheep except the heads and ears must remain immersed for not less than one minute.
Plunge the head under at least twice, allowing time to breathe between plunges.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Symptoms:
Diazinon is an organophosphorous compound with cholinergic activity, which in excessive doses stimulates the parasympathetic nervous system.
Signs of overdose in animals are abdominal pain, diarrhoea, salivation, muscular tremors and constriction of the pupils.
Death may occur from respiratory failure.
Emergency procedures/antidotes:
Veterinary advice should be sought.
Atropine sulphate is the antidote.
If necessary injections may be repeated every 30 minutes.
4.11 Withdrawal Period(s)
Meat and offal: 35 days
Not permitted for use in lactating ewes producing milk for human consumption.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
ATCvet code:
QP53AF03:
organophosphorous compounds
5.1 Pharmacodynamic properties
Diazinon is a non-systemic insecticide with some acaricidal action.
Diazinon acts as an irreversible inhibitor of the enzyme cholinesterase.
It irreversibly phosphorylates the esterase site of cholinesterase resulting in an increase in acetylcholine.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Multisol H585 (hydrocarbon solvent)
Brennspec 947
Soya Bean Oil (epoxidised)
6.2 Incompatibilities
It is compatible with most pesticides but should not be combined with copper fungicides.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and composition of immediate packaging
Fluorinated HDPE bottles with HDPE cap.
The cap includes a socket to connect to the CTS unit and a tamper evident tab.
Pack sizes: 1.5 litres, 2.27 litres (½ gallon) and 4.54 litres (1 gallon).
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials Dangerous to fish and other aquatic life.
Harmful to game, wild and domestic birds and mammals.
Empty containers should not be re-used.
Wash out thoroughly and place rinsings into the dip bath.
Dispose of containers by approved means.
Store well away from children, animals, feedstuffs and food.
Only buy sufficient product for your immediate needs.
Do not dispose of the dip concentrate on the farm.
Any unwanted product should be disposed of by a reputable specialist waste disposal contractor.
If you have a suitable area of land, the spent dip wash may be disposed of by applying no more than 5,000 litres/hectare (450 gallons/acre) making sure that it cannot enter rivers, streams or lakes by run-off.
Remove livestock from the land before spreading.
Alternatively, a reputable waste disposal contractor should dispose of the spent dip.
When the CTS dispensing unit requires disposal, ensure the system is thoroughly rinsed out according to the instructions provided with the unit Dispose of the CTS unit in accordance with the guidelines from your local waste regulation authority.
Fisheries Acts 1959 to 1980 and Local Government (Water Pollution) Act 1977.
As these preparations are highly injurious to fish and stream life, care should be taken to prevent them entering rivers and streams and users are warned that it is an offence to permit the entry or discharge into any water of any deleterious matter liable to render the water poisonous or injurious to fish, spawning grounds, or the food of any fish.
7 MARKETING AUTHORISATION HOLDER
Hygeia Chemicals Limited
Oranmore
Co. Galway
8 MARKETING AUTHORISATION NUMBER(S)
VPA 10203/001/001
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30th September 2009
10 DATE OF REVISION OF THE TEXT
June 2012
