SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Deltanil 10 mg/ml Pour-on Solution for cattle and sheep

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

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 treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs.

On cattle: For the treatment and prevention of infestations by both sucking and biting lice, including Bovicolabovis, Solenopotes capillatus, Linognathus vituliand Haematopinus eurysternus. Also as an aid in the treatment and prevention of infestations by both biting and nuisance flies including Haematobia irritans, Stomoxys calcitrans, Musca species and Hydrotaea irritans.

On sheep: For the treatment and prevention of infestations by ticks Ixodes ricinusand by lice (Linognathus ovillus, Bovicola ovis), keds (Melophagus ovinus) and established blowfly strike (usuallyLucilia spp).

On lambs: For the treatment and prevention of infestations by ticks Ixodes ricinusand by lice Bovicola ovis.

4.3 Contraindications

Do not use on convalescent or sick animals.

Do not use in cases of known hypersensitivity to the active substance or any of the excipients.

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.

4.4 Special warnings <for each target species>

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

To avoid resistance, the product should only be used if the susceptibility of the local fly population to the active substance is assured. If clinical signs do not resolve following treatment, the diagnosis should be revised.

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

In countries with recognized resistance to deltamethrin the use of the product should ideally be based on results of susceptibility testing. Please, ask your veterinarian for further information.

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

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, or lack of calibration of the dosing device.

4.5 Special precautions for use

Special precautions for use in animals

The product is for external use only.

Avoid contact with eyes and mucous membranes as Deltamethrin is an irritant.

Care should be taken to prevent licking of the product. Avoid use of the product during extremely hot weather and ensure animals have adequate access to water.

The product should only be administered onto undamaged skin as toxicity is possible due to absorption from major skin lesions. However, signs of local irritation may occur after treatment as skin may be already affected by infestation.

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

Persons with known hypersensitivity to the product or one of its components should avoid contact with the veterinary medicinal product.

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 re-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, seek medical advice and show the package leaflet to the physician.

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.

Other precautions

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 year on the same pasture.

4.6 Adverse reactions (frequency and seriousness)

Squamosis and pruritus have been seen in some cattle during the 48 hours after treatment.

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 use with any other insecticide or acaricide. Especially, in combination with organo-phosphorous compounds, the toxicity of deltamethrin is enhanced.

4.9 Amounts to be administered and administration route

For external use.

Dose:

Cattle: 100 mg of deltamethrin per animal corresponding to 10 ml of product.

Sheep: 50 mg of deltamethrin per animal corresponding to 5 ml of product

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

Administration:

The product should be applied using an appropriate device :

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

- for the 2.5 litre bottle and the 2.5 litre and 4.5 litre 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.