SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Deltacert 10 mg/ml Pour-on Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains

Active substance:

Deltamethrin 10 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Pour-on Solution

A slightly yellowish clear oily solution

4. CLINICAL PARTICULARS

4.1 Target species

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 ricinusand lice Bovicola ovis.

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 convalescent or sick animals.

4.4 Special warnings

To avoid resistance, the product should only be used if the susceptibility of the local fly population to the active substance is assured.

Cases of resistance to deltamethrin have been reported in stinging and nuisance flies in cattle and lice in sheep.

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:

- too frequent and repeated use of ectoparasiticides from the same class over an extended period of time

- underdosing which may be due to underestimation of bodyweight, misadministration of the product.

The product will reduce the number of flies resting directly on the animal but it is not expected to eliminate all flies on the farm. The strategic use of the product should, therefore, be based on local and regional epidemiological information about the susceptibility of parasites, and used in association with other pest management methods.

4.5 Special precautions for use

For external use only.

Do not apply on or near the animal’s eyes or mucous membranes.

Extra-label use of the product in the non-target species dogs and cats can lead to toxic neurological signs (ataxia, convulsions, tremors), digestive signs (hypersalivation, vomiting) and may be fatal.

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.

Deltamethrin is toxic to dung insects. The risk to 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 a single treatment per season on the same pasture.

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, lactation or lay

Laboratories studies (rat, rabbits) have not produced any evidence of teratogenic or embryotoxic effects.

No studies have been conducted with the product in pregnant cows and ewes.

The product can be used in cows and ewes during pregnancy and lactation, according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

Do not mix with any other insecticide or acaricide

4.9 Amounts to be administered and administration route

For external use.

Dose:

Cattle: 100 mg of deltamethrin per animal corresponding to10 ml

Sheep: 50 mg of deltamethrin per animal corresponding to5ml

Lambs (under 10 kg bodyweight or 1 month of age):25 mg of deltamethrin per animal corresponding to 2.5ml

Administration:

The product should be applied using an appropriate device :

- for the 0.5L and 1L bottles, the product is supplied with a dosing cup

- for the 2.5L bottle and the 2.5L and 4.5L flexible pouches, it is recommended to use an appropriate dosing gun. The flexible pouches should be carried in an appropriate rucksack.

An appropriate applicator should comply with the following specifications :

• it should deliver doses of 2.5 mL, 5 mL and 10 ml.

• it should be supplied with a flexible “hose” of internal diameter between 10 mm and 14 mm.