Summary of Product Characteristics

Ectron 10 mg/ml Spot-on Solution for Cattle and Sheep

Active Substance mg/ml

Deltamethrin 10.0

For the full list of excipients, see section 6.1

Spot-on Solution

A clear pale gold oily liquid

4. Clinical Particulars

Cattle and sheep.

4.2 Indications for use, Specifying the Target Species

As a topical application for the control of lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs.

On cattle:for the control of both sucking and biting lice, including Damalinia bovis, Solenopotes capillatus, Linognathus vituliand Haematopinus eurysternuson 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 ricinusand of lice and keds and established blowfly strike.

On lambs: For the control of ticks Ixodes ricinus and lice Bovicola ovis.

4.3 Contraindications

None.

4.4 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.

4.5 Special Precautions For Use

i) Special precautions for use in animals

For external use only.

ii) Special Precautions to be taken by the person administering the product to animals

Wear protective clothing including 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 label.

Advice to medical practitioners:Advice on clinical management is available from the National Poisons Information Service.

iii) Other precautions

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.

.

4.6 Adverse Reactions (frequency and 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.

4.7 Use during pregnancy or lactation

No special precautions are recommended.

4.8 Interaction with other medicinal products and other forms of interaction

Do not mix any other insecticide or acaricide with Ectron Spot-on Solution.

4.9 Amounts to be administered and administration route

The product should be applied using an appropriate application device:

• For the 250ml and 500ml presentations 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.

The recommended use of the application devices is illustrated below.