Summary of Product Characteristics

1. Name of the veterinary medicinal product

Dermoline Sweet Itch Lotion. - Pour-on solution.

2. Qualitative and Quantitative Composition.

Active substance(s) %v/v

Piperonyl butoxide 100% 0.5

Pyrethrum extract 25% 0.4

For a full list of excipients, see section 6.1

3. Pharmaceutical form.

Pour-on solution

Clear oily liquid

4. Clinical particulars.

4.1 Target species;

Horses

4.2 Indications for use, specifying the target species;

As an aid in the control of Sweet Itch in horses

4.3 Contra indication;

Not to be used on horses with hypersensitivity to the active ingredients.

4.4 Special warnings for each target species;

Rarely, horses are sensitive to this product. It is recommended that a small skin test under the mane should be carried out 24 hours before use as directed. For external use only.

4.5 Special precautions for use

i) Special precautions for use in animals

None

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

Wear rubber gloves while applying the product.

Avoid contact with eyes. In case of accidental eye contact, rinse with clean, fresh water. If eye irritation persists, seek medical advice.

Persons who are hypersensitive (allergic) to pyrethrum extract should handle the product with care.

Treated animals should not be handled until dry.

Do not eat, drink or smoke while using this product.

Wash hands and exposed skin after use.

4.6 Adverse reactions (frequency and seriousness);

Occasional skin reactions. Some horses may be sensitive to this product. If this is suspected, test a small area of the body 24 hours before use as directed.

4.7 Use during pregnancy, lactation or lay;

No specific studies have been conducted in pregnant or lactating horses.

4.8 Interaction with other medicinal products and other forms of interaction;

Interaction with medicinal products – None known.

Other- None known.

4.9 Amounts to be administered and administration route;

For topical administration. Apply the lotion in advance of the start of the season when the midge Culicoidesbecomes active. First application; apply liberally to the mane and tail with a soft brush, parting the hair on the mane and tail to apply the lotion to the skin. Second application; top up once or twice daily with a smaller amount of lotion throughout the spring, summer and early autumn. After shampooing the mane and tail, a heavy application should be made again. Horses which are prone to Sweet Itch should be stabled if possible at dawn and dusk.

4.10 Overdose (symptoms, emergency procedures, antidotes) if necessary;

Pyrethrins, being of natural extracts, are unlikely to cause reactions (see also 4.3)

4.11 Withdrawal period(s);

Not to be used on horses intended for human consumption.

Treated horses may never be slaughtered for human consumption

The horse must have been declared as not intended for human consumption under national horse passport legislation

5. Pharmacological Properties.

ATCvet code QP53AC51

5.1 Pharmacodynamic properties;

Pyrethrins are insecticides, the precise mode of action remains uncertain, but comprise three major stages (a) knockdown (b) paralysis (c) death. Piperonyl butoxide is a synergist which markedly enhances the potency of pyrethrins primarily by its ability to inhibit detoxification of pyrethrins by the insect.

5.2 Pharmacokinetic properties;

Pyrethrins I and II undergo rapid and extensive mammalian metabolism following both oral and parenteral administration which probably accounts for the low toxicity of these compounds in mammals.

Piperonyl butoxide is also undergoes metabolism in the body

Both pyrethrins and piperonyl butoxide are poorly absorbed through intact skin.

6. Pharmaceutical particulars

6.1 List of excipients

Liquid Paraffin

6.2 Incompatibilities –

None Known.

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^oC. Store in tightly closed original container. Protect from direct sunlight. Keep away from food, drink and animal feedstuffs.

6.5 Nature and composition of immediate packaging.

500 ml white, high density polyethylene bottles with low density polyethylene two piece closure with spout.

6.6 Special precautions for disposal of unused veterinary medicinal products or waste materials derived from the use of such products -

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Harmful to aquatic life. Do not contaminate ponds, waterways or ditches with the product or used container.

7. Authorisation holder.

Battle, Hayward and Bower Ltd

Crofton Drive,

Lincoln.

LN3 4NP

8. Marketing Authorisation Number

Vm00676/4112

9. Date of the first authorisation

28^thAugust 1992

10. Date of revision of the text

January 2009