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Paracide

Main information

  • Trade name:
  • Paracide 62 %w/v, Concentrate for Dip Emulsion
  • Available from:
  • Animax Ltd
  • Pharmaceutical form:
  • Concentrate for dip solution
  • Prescription type:
  • POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Paracide 62 %w/v, Concentrate for Dip Emulsion
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Sheep
  • Therapeutic area:
  • Ectoparasiticide sheep dip

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 14016/4007
  • Authorization date:
  • 13-08-1985
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Revised April 2015

AN: 01745/2014

SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of Veterinary Medicinal Product

Paracide 62 %w/v, Concentrate for dip emulsion.

2. Name and proportion of each Active Substance

Dimpylate (Diazinon) 62% w/v

Name and proportion of each Excipient if knowledge of the Excipient is

needed for Safety reasons

Propylene oxide 1.03% w/v

3. Pharmaceutical Form

Concentrate for Dip emulsion

4. Clinical Particulars

4.1 Target species

Sheep

4.2 Indications for use, specifying the target species

For the control of sheep scab, blowfly, ticks, keds and lice on sheep.

4.3 Contra-indications

Do not use the product undiluted.

Do not retain the dip wash for a second day’s dipping.

.

4.4 Special warnings for each target species

Efficacy has not been demonstrated for the use of the product in

shower dips or jetting races.

As with all dips, the effectiveness of the uptake of insecticide may be

reduced if the bath is overloaded with organic material. It is

recommended that dip baths containing this product be discarded when

the bath becomes too fouled with droppings, etc.

The dipwash in baths of 250 gallons (1050 litres) or less, containing this

product should be discarded after the passage of approximately 400

sheep through the bath. The dipwash in baths larger than 250 gallons

(1050 litres) should be discarded after the passage of 1 sheep for every

2 litres (2 sheep to 1 gallon) of the initial bath volume.

Page 1 of 9

Revised April 2015

AN: 01745/2014

4.5 Special Precautions for Use

(i) Special precautions for use in animals

As this is an organophosphorous sheep dip an interval of at least 14

days should elapse between dipping and drenching with any drench

etc. containing levamisole or an organophosphorous compound

The dip should be freshly made and only used on the day of

preparation. Do not retain the dip wash for a second day’s dipping.

Prepare the bath carefully and dip following the detailed instructions.

Ensure the bath and water are clean before starting to dip. This

product does not contain a bacteriostat and 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.

Avoid extremes of heat and cold as well as thunder and wet weather.

As far as possible, do not carry out dipping in the rain or when the

fleece is wet. Choose a fine day free from impending rain. In winter, do

not dip sheep in very frosty weather and, if available, carry out dipping

in a well ventilated sheltered yard.

Dipping in the early morning is best so that the sheep can dry before

the evening. This is especially advised where dipping in hot weather is

unavoidable because the temperature is cooler up to 9 am.

Do not dip sheep when they are tired, heated, thirsty, suffering from

scour or wounds or otherwise out of condition, nor when full of food.

Keep the sheep off food and rest them quietly near the bath for a few

hours both before and after dipping, making sure they are not crowded

together.

Drain them well in a bare place and do not return them to pasture until

they have ceased dripping.

Rams and fat sheep are susceptible to immersion shock, therefore

never dip them on a sultry day and always dip them separately about

the middle of the general dipping, carefully assisting them through the

bath.

Care must be taken to avoid sheep inhaling or swallowing the wash.

Dangerous to fish and other aquatic life. Do not contaminate surface

waters.

Harmful to game, wild and domestic birds and mammals. Do not allow

access to dilute dip

Page 2 of 9

Revised April 2015

AN: 01745/2014

(ii) Special precautions to be taken by the person administering the

veterinary medicinal product

PREPARATION FOR DIPPING:

Diazinon is an ORGANOPHOSPHORUS compound. DO NOT USE if

under medical advice not to work with such compounds.

Only use in a dip bath that is well designed and hazard free. Check that

all those involved are adequately trained and competent.

Keep children well away from all dipping operations.

Make sure that everyone involved in dipping operations has the

recommended protective clothing and insist that they wear it.

Ensure you have spare protective clothing available in case any items

become damaged (see below for ‘PROTECTIVE CLOTHING’).

Dipping should only be carried out in a well-ventilated area, preferably

outdoors.

PROTECTIVE CLOTHING:

The recommended protective clothing is:

Face shield (when handling the concentrate)

Bib apron (over boiler suit) or waterproof coat (PVC or nitrile)

Gloves (Non-lined or flock lined, PVC or nitrile, heavy duty

gauntlet style – 0.5mm thick and at least 300mm long)

Waterproof leggings/trousers (PVC or nitrile to be worn outside

your boots)

Wellington boots.

DURING DIPPING:

Immediately wash off sheep dip, particularly dip concentrate, if it gets

on your skin or in your eyes.

Before leaving the work area wash and remove protective clothing and

do not smoke, drink, eat or use the toilet during dipping operations.

Always wash hands, face and exposed skin immediately after leaving

the work area.

Immediately remove heavily contaminated clothes and wash

contaminated areas of skin – see further instructions below under

‘Medical advice to users’ and ‘Disposal’.

If you need to handle the sheep in the weeks following dipping wear

protective clothing because dip residues remain on the fleece.

Page 3 of 9

Revised April 2015

AN: 01745/2014

MEDICAL ADVICE TO USERS:

If you have previously felt unwell after using a product containing an

organophosphorus compound, consult your doctor before working with

this product and show your doctor this label.

If you feel unwell after using this product consult your doctor and show

your doctor this label.

Treat any cases of heavy contamination as an emergency. You should

go straight to hospital after removing contaminated clothing, and rinse

with plenty of water areas of the skin that came into contact with the

sheep dip. If sheep dip has been swallowed go straight to hospital and

take the product label with you.

MEDICAL ADVICE TO DOCTORS:

Poisoning from organophosphorus compounds in sheep dips results

from blockage of acetylcholinesterase, with a resultant over-activity of

acetylcholine.

Symptoms include headache, exhaustion and weakness, mental

confusion together with blurred vision, excessive salivation and

sweating, cramp like abdominal pain, chest tightness, diarrhoea,

constricted pupils and bronchorrhea. These may develop for up to 24

hours after exposure.

Severe poisoning can include general muscle twitching, loss of co-

ordination, extreme difficulty with breathing and convulsions, which may

lead to unconsciousness in the absence of medical treatment. Treat

symptomatically and seek urgent hospital transfer if poisoning is

suspected.

AFTER DIPPING:

Always cover the bath when not in use, and take action to prevent

accidents to both humans and animals.

Do not house freshly dipped sheep in an enclosed building.

In the 3 month period after dipping you are advised not to shear sheep.

(iii) Other precautions

For external use only.

If you sell the sheep you should tell the new owner when the animals

were last dipped. If you take sheep to market it is good practice to ask

the auctioneer to record (and pass on the new owner) the date your

animals were last dipped particularly if they were dipped during the last

3 months.

Never re-use concentrate containers.

Page 4 of 9

Revised April 2015

AN: 01745/2014

4.6 Adverse reactions (frequency and seriousness)

Immersion shock has been reported, particularly in rams and fat sheep.

See section 4.5. Post dipping lameness caused by bacterial build up in

the bath has also been described if the bath is not cleaned and

replaced according to instructions.

4.7 Use during pregnancy, lactation or lay

Pregnant sheep may become stressed if dipped. If dipping of, pregnant

sheep is essential they should be gently lowered into the bath and

assisted out.

4.8 Interaction with other medicinal products and other forms of

interaction

This dip must not be used in conjunction with any other dip and must be

diluted with water in the recommended proportions.

As this is an organophosphorous sheep dip an interval of at least 14

days should elapse between dipping and drenching with any drench

etc. containing levamisole or an organophosphorous compound.

4.9 Amounts to be administered and administration route

This product is supplied in containers that are part of a Closed Transfer

System and should only be dispensed through the Animax Manual

Pump. Do not attempt to remove the container fittings under any

circumstances. To do so would invalidate the legality of the dipping

operation, remove any product guarantee and be a breach of health

and safety practice. The container is fitted with a tamper evident insert

that cannot be removed without extreme force. This product should only

be used at an ambient temperature of between 5°C and 25°C. If used

outside these temperatures inaccurate dosing will occur. Before dipping

commences, ensure that the dip bath is cleaned and prepare a fresh

solution as described below.

INITIAL BATH: Dilute at a rate of one part of dip concentrate to 1500

parts of clean water.

Paracide 62 Initial Dilution at a rate of 1 litre of Paracide 62 to 1500

litres of clean water. If your dip bath is calibrated in gallons you get 4.55

litres in 1 gallon (e.g. 22 gal = 100L)

BATH VOLUME

IN LITRES 600 1200 2400 4800

VOLUME OF

PARACIDE 62 TO

ADD 400 ml 800 ml 1.60 litres 3.20 litres

Page 5 of 9

Revised April 2015

AN: 01745/2014

ALL REPLENISHMENTS: Dilute at the rate of 1 part of dip

concentrate to 1000 parts of clean water. Replenish the bath after the

passage of every 20 sheep through the bath according to the table

below. If the drain back facilities are such that the bath volume is not

depleted to the minimum volume indicated in the table after the

passage of 20 sheep, it is necessary to replenish the bath with 50 ml of

dip concentrate together with the amount of water required to return the

bath to the original volume.

Paracide 62 topping up system. Top up after 20 sheep at a rate

of 1 litres of Paracide 62 to 1000 litres of clean water. If the volume

of the dip bath drops by less than 50 litres after 20 sheep still add

50 ml of Paracide 62 and top up with water to the original level.

BATH LEVEL

DROP IN

LITRES 50 75 100 150 200 250

VOLUME OF

PARACIDE

62 TO ADD 50

ml 75

ml 100

ml 150

ml 200

ml 250

ml

4.10 Overdose (symptoms, emergency procedures, antidotes) if

necessary

Diazinon is an organophosphorus compound with cholinergic activity,

which in excessive doses stimulates the parasympathetic nervous

system.

The symptoms of overdosing in animals are abdominal pain, diarrhoea,

salivation, muscular tremors and constriction of the pupils. Death may

occur from respiratory failure.

Should toxicity symptoms appear, atropine sulphate is antidotal and

should be given either subcutaneously or intramuscularly at 0.1 - 0.2

mg/kg bodyweight until signs of atropinisation appear, i.e. decreased

salivation, dilation of pupils and tachycardia. Give additional doses if

necessary as often as every 10 minutes. Close surveillance and a mild

degree of atropinisation should be maintained for 25 - 48 hours or

possibly longer. In severe cases, if pralodoxime chloride is available,

give intravenously at 20 mg/kg bodyweight and repeat after one hour. In

such cases, atropine may be administered concurrently.

4.11 Withdrawal Periods

Meat and offal: 70 days

Do not treat sheep producing milk for human consumption

Page 6 of 9

Revised April 2015

AN: 01745/2014

5. Pharmacological Properties

Pharmacotherapeutic group: Ectoparasiticides for topical use, incl.

Insecticides, organophosphorous compounds,

ATCvet code: QP53AF03

5.1 Pharmacodynamic properties

Diazinon is an organophosphate ester with strong insecticidal and

acaricidal activities; it exerts its effect by contact and by stomach and

respiratory toxicity in ectoparasites.

The mode of action of the compound is by cholinesterase inhibition

similar to other organophosphate insecticides.

Diazinon has been used successfully to control both agricultural and

veterinary parasites in a variety of formulations, including emulsifiable

concentrate, wettable powder, aerosol and dusting powder.

Paracide 62, when used at the recommended initial and replenishment

rates will eradicate and provide residual protection against sheep scab,

blowfly, ticks, keds and lice on sheep.

5.2 Pharmacokinetic properties

Diazinon is readily metabolised, largely by cleavage of the pyrimidinyl

phosphorous ester bond and eliminated predominantly via the urine.

Following plunge dipping as recommended above mean fleece levels of

c 3,900 mg/kg (ppm) are deposited in the fleece bound to the lanolin

component. These level decline over time to c 700 mg/kg (ppm) at 5

weeks post dipping and 150 mg/Kg (ppm) at

7 - 8 weeks post dipping. There is considerable variation between

individual sheep results.

Percutaneous absorption from this depot in wool fat is low.

The compound is relatively stable at normal temperatures and shows

some residual activity.

6. Pharmaceutical Particulars

6.1 List of excipients

Propylene oxide

Liquid paraffin

Polysorbate 80

Castor oil, polyoxyl

Sorbitan trioleate

6.2 Major Incompatibilities

Diazinon is incompatible with copper compounds and oxidising agents.

The material is slowly decomposed by water and dilute acids.

Diazinon is incompatible with levamisole.

Page 7 of 9

Revised April 2015

AN: 01745/2014

6.3 Shelf-life

Concentrate – 2 years.

Diluted – 1 day.

The dip wash must be discarded and disposed of safely at the end of

the day.

6.4 Special Precautions for Storage

Store in tightly closed original container. Do not store above 25 C.

Keep in a store designed for the storage of approved pesticides.

Store away from food, drink and animal feedstuffs.

6.5 Nature and Contents of immediate packaging

5 and 10 litre steel drums containing a clear pale amber coloured

emulsifiable concentrate ectoparasiticidal sheep dip for dilution with

water. Each drum is sealed with a special non-removable cap that

allows the product to be dispensed through a closed transfer (CT)

System, the Animax Manual Pump.

6.6 Special Precautions for the Disposal of Unused Veterinary

Medicinal Products or Waste Material derived from the use of such

products, if appropriate

It is an offence to permit any poisonous, noxious or polluting matter to

enter any river, stream or water course.

Any unwanted product should be disposed of by a licensed waste

disposal contractor.

Empty containers should be rinsed out according to the instructions

supplied with the CT system and the rinsings pumped into the dip bath.

This process must be carried out three times. The rinsed containers

should be punctured at the dipping site and can then be disposed of in

accordance with any guidance from an appropriate waste regulation

authority.

To dispose of used sheep dip an authorisation under the Groundwater

Regulations 1998 is required. To apply for an authorisation contact the

Environment Agency or Scottish Environment Protection Agency

(SEPA) or the Northern Ireland Environment Agency. Alternatively,

spent dip wash should be disposed of by a licensed waste disposal

contractor.

7. Marketing Authorisation Holder

Animax Ltd

Shepherds Grove West

Stanton

Bury St Edmunds

Suffolk

IP31 2AR

Page 8 of 9

Revised April 2015

AN: 01745/2014

8. Marketing Authorisation Number

Vm 14016/4007

9. Date of the first authorisation

Date: 13 August 1985

10. Date of revision of the text

Date: April 2015

APPROVED 30/04/15

Page 9 of 9

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