Cattle, sheep and goats.

Treatment of infestations by the following internal and external parasites sensitive to eprinomectin:

Warbles (parasitic stages): Hypoderma bovis, Hypoderma lineatum

Mange mites: Sarcoptes scabiei var. bovis

The product protects treated animals against reinfestations with:

Do not use in other animal species.

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

Do not administer orally or by intramuscular or by intravenous injection.

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 anthelmintics 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 (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

If there is a risk for re-infection, the advice of a veterinarian should be sought regarding the need for and frequency of repeat administration.

Resistance to other macrocyclic lactones has been reported in parasite species in cattle within the EU. Therefore, use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

Resistance to eprinomectin in parasite species in goats and sheep has been reported within the EU. Therefore, use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

Usual aseptic procedures for administration of a parenteral injection should be followed.

Not to be used in other species; avermectins can cause fatalities in dogs, especially Collies, Old English Sheepdogs and related breeds and crosses, and also in turtles/tortoises.

The death of warble fly larvae in the oesophagus or spinal cord canal may lead to secondary reactions. In order to avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or the spine, it is recommended to administer the product at the end of the period of fly activity and before the larvae reach their resting site.

People with known hypersensitivity to eprinomectin or to any of the excipients should avoid contact with the veterinary medicinal product

The veterinary medicinal product causes serious eye irritation. Avoid contact with the eyes. Wash any splashes from eyes immediately with water.

This product may cause neurotoxicity. Care should be taken when handling the product to avoid self-injection. In case of accidental injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Avoid contact with the skin. Wash any splashes from skin immediately with water. Avoid oral exposure. Do not eat, drink or smoke while handling the veterinary medicinal product. Wash hands after use.

The excipient glycerol formal may cause harm to the unborn child. In addition, the active substance eprinomectin can be transferred to breast milk. Pregnant/breast- feeding women and women of childbearing age should therefore avoid exposure to this product.

Eprinomectin is very toxic to dung fauna and aquatic organisms, 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 eprinomectin (and products of the same anthelmintic class) in cattle, sheep and goats. The risk to aquatic ecosystems will be further reduced by keeping treated cattle, sheep and goats away from water bodies for two to five weeks after treatment.

None

*Resolves within 7 days but induration may persist for in excess of 21 days.

*Resolves within 16 to 18 days.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.

Can be used during pregnancy and lactation.

The safety of eprinomectin during pregnancy in sheep and goats has not been tested. Use only according to the benefit/risk assessment of the responsible veterinarian in these species.

Since eprinomectin binds strongly to plasma proteins, this should be taken into account if it is used in association with other molecules having the same characteristics.

Subcutaneous use. For single administration only.

Administration of 0.2 mg of eprinomectin per kg bodyweight; corresponding to 0.1ml of the veterinary medicinal product per 10 kg bodyweight.

In goats, the volume per injection site should not exceed 0.6 ml.

Do not exceed 30 broachings per vial. If more than 30 broachings are required, use of a draw off needle is recommended.

Do not exceed 20 broachings per vial. If more than 20 broachings are required, use of a draw off needle is recommended.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.

After subcutaneous administration of up to 5 times the recommended dose, no adverse events were observed except a transient reaction (swelling followed by induration) at the injection site.

The safety of the product in goats has not been demonstrated in overdose studies.

- Meat and offal: 63 days

- Milk: zero hours.

- Meat and offal: 42 days

- Milk: zero hours.

- Meat and offal: 42 days

- Milk: zero hours.