SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Deosect 5% w/v Concentrate for Cutaneous Spray Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances:

% w/v

Cypermethrin technical Cis 50: Trans 50 5.0 (0.1% w/v when diluted)

Excipient(s):

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cutaneous spray, solution

Clear Yellow liquid free from solids

4. CLINICAL PARTICULARS

4.1 Target species

Horses.

4.2 Indications for use, specifying the target species

Topical spray to control flies and lice on horses.

4.3 Contraindications

None

4.4 Special warnings

Avoid spraying directly into animal’s eyes. For external use only.

4.5 Special precautions for use

i) Special precautions for use in animals

Do not apply to any lesions where the skin is broken.

Do not spray in or near milking parlours or where milking machinery may be contaminated.

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

FLAMMABLE

Wear impermeable gloves, face shield and rubber boots when handling the concentrate, diluted liquid and when spraying animals.

Use in a well-ventilated area and avoid inhaling the spray mist. If splashed in the eye or on the skin, wash with plenty of clean, running water immediately and seek medical attention.

Remove contaminated clothing immediately and wash before re-use.

Do not smoke or eat while handling the product.

Wash hands and exposed skin after handling this product and before meals.

4.6 Adverse reactions (frequency and seriousness)

This product belongs to the pyrethroid group. Possible undesirable effects can be irritation and allergic reactions on the skin.

4.7 Use during pregnancy, lactation or lay

The product can be safely used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Deosect must be diluted and mixed with water to make a solution just before use. A knapsack, hand sprayer or sponge may be used to apply the solution. The solution should be used within 24 hours. Avoid spraying directly into animal’s eyes.

One litre of Deosect should be diluted with 50 litres of water. Alternatively, the following table may be used.

Deosect	Water
10ml	500ml
20ml	1 litre
100ml	5 litre
200ml	10 litre

A medium fine spray is advisable to avoid fogging of the diluted Deosect. Careful attention must be paid to total animal coverage, especially the face, legs, back and hindquarters. The following amounts should be used.

Adult horses	-500 ml of diluted solution per animal
Ponies	-125 ml of diluted solution per animal

Fly control:

The application of the solution should commence at the onset of the fly season and be repeated monthly for general fly control and every two weeks for severe head and face fly control.

Lice control:

Apply when lice are observed and repeat as necessary at a minimum interval of 14 days.

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

Deosect is of low toxicity and acute poisoning is unlikely to occur.

4.11 Withdrawal period

Not to be used in animals 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: QP53AC08

Cypermethrin is a non-systemic pyrethroid insecticide with contact action. It acts on the central and peripheral nervous system in very low doses.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tensiofix B 7438

Tensiofix B 7453

Cyclohexanone

Shellsol A

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after dilution according to directions: 24 hours

6.4 Special precautions for storage

Store in original container tightly closed in a safe place away from food, drink and animal feedstuffs.

Protect from frost.

Do not store above 25ºC.

6.5 Nature and composition of immediate packaging

Coex plastic bottles closed with a polypropylene cap. Contains either 250 ml or 1 litre. Not all pack sizes may be marketed.

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

DANGEROUS to fish and crustaceans. Do not contaminate ponds, waterways or ditches with the product or used containers.

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

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

1^st Floor, Birchwood Building

Springfield Drive

Leatherhead

Surrey

KT22 7LP

8. MARKETING AUTHORISATION NUMBER

Vm 42058/4033

9. DATE OF FIRST AUTHORISATION

26 April 1993

10. DATE OF REVISION OF THE TEXT

August 2020

Approved: 26 August 2020