Beef and dairy cattle

Treatment of infestations by the following parasites sensitive to eprinomectin:

Gastrointestinal roundworms (adults and L4 larvae): Ostertagia ostertagi (including inhibited L4 larvae), Ostertagia lyrata (only adults), Haemonchus placei, Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia sp. (including inhibited L4), Cooperia oncophora, Cooperia punctata, Cooperia pectinata, Cooperia surnabada, Bunostomum phlebotomum, Nematodirus helvetianus, Oesophagostomum radiatum, Oesophagostomum sp. (only adults), Trichuris discolor (only adults);

Lungworms: Dictyocaulus viviparus (adults and L4);

Warbles (parasitic stages): Hypoderma bovis, Hypoderma lineatum;

Mange mites: Chorioptes bovis, Sarcoptes scabiei var. Bovis;

Sucking lice: Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus;

Biting lice: Damalinia bovis;

Flies: Haematobia irritans.

The product protects the animals against reinfestations with:

- Nematodirus helvetianus for 14 days.

- Trichostrongylus axei and Haemonchus placei for 21 days.

- Dictyocaulus viviparus,,Cooperia oncophora, Cooperia punctata, Cooperia surnabada, Oesophagostomum radiatum and Ostertagia ostertagi for 28 days.

This product is formulated only for topical application to beef and dairy cattle, including lactating dairy cattle. Do not use in other animal species.

Do not administer orally or by injection.

Do not use in animals with known hypersensitivity to the active ingredient or to any of the excipients.

Avermectins may not be well tolerated in non-target species (including dogs, cats and horses). Cases of mortality are reported in dogs, especially Collies, bobtail and related breeds and crosses, and also in turtles/tortoises.

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.

To date no resistance to eprinomectin (a macrocyclic lactone) has been reported in cattle within the EU. However 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.

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.

For the best results the product should be part of a planned programme to control both internal and external parasites of cattle based on the epidemiology of these parasites.

For external use only.

To avoid adverse reactions due to the death of warble larvae in the oesophagus or backbone, it is recommended to administer the product after the end of the swarming of the warbles and before the larvae reach their sites in the body; consult a veterinary surgeon to know the appropriate treatment period.

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.

For effective use, the product should not be applied to areas of the backline covered with mud or manure. The product should be applied only on healthy skin.

This product may be irritating to the skin and eyes and may cause hypersensitivity (allergic reactions). Avoid direct contact with the skin or eyes.

Wear rubber gloves and protective clothing when applying the product.

If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water.

Wash hands after use.

Do not smoke, eat or drink while handling the product.

Should clothing become contaminated, remove as soon as possible and wash before re-use.

In the event of ingestion, wash out mouth with water and seek medical advice. This product may affect the central nervous system if accidentally ingested.

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

Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may accumulate in sediments. Faeces containing eprinomectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms. Following treatment of cattle with the product, levels of eprinomectin that are potentially toxic to dung fly species may be excreted over a period of more than 4 weeks and may decrease dung fly abundance during that period. In case of repeated treatments with eprinomectin ((as with products of the same anthelmintic class) it is advisable not to treat animals every time on the same pasture to allow dung fauna populations to recover.

Eprinomectin is inherently toxic to aquatic organisms. The product should be used only according to the label instructions. Based on the excretion profile of eprinomectin when administered as the pour-on formulation, treated animals should not have access to watercourses during the first 7 days after treatment.

Transient licking reactions, skin tremor at the administration site, minor local reactions such as the occurrence of dandruff and skin scales at the administration site have sometimes been observed.

Laboratory studies (rat, rabbit) have not produced any evidence of a teratogenic or embryotoxic effects due to the use of eprinomectin at therapeutic doses. The safety of the veterinary medicinal product in cattle has been established during pregnancy and lactation and in reproductive bulls. Can be used during pregnancy and lactation as well as in reproductive bulls.

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

Pour-on external use.

To be administered topically in one single treatment at the dose rate of 500 μg eprinomectin per kg bodyweight equivalent to 1 ml per 10 kg bodyweight.

Apply the pour-on solution along the mid-line of the back in a narrow strip between the withers and tail head.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible and accuracy of the dosing device should be checked. If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- and overdosing.

All the animals belonging to the same group should be treated at the same time.

Remove the protective aluminium seal from the bottle.

Screw the dosing cup to the bottle. Set the dose by turning the top section of the cup to align the correct bodyweight with the pointer. When body weight is between marking, use the higher setting.

Hold the bottle upright and squeeze it to deliver a slight excess of the required dose as indicated by the calibration lines.

By releasing the pressure, the dose automatically adjusts to the correct level.

Take the dosing cup off the bottle after use and screw the cap on the bottle.

Connect an appropriate dosing gun and draw-off tubing to the back-pack as follows.

Remove the protective aluminium seal from the bottle.

Replace the shipping cap with the cap having the draw-off tubing. Tighten the draw-off cap.

Connect one side of the tube to the draw-off cap and the other side to the dosing gun.

Gently prime the dosing gun, checking before use that all connections are tight. Follow the gun manufacturer’s instructions for adjusting the dose and proper use and maintenance of the dosing gun and draw-off tubing. When body weight is between marking, use the higher setting.

Connect an appropriate dosing gun to the FlexiBag as follows.

Connect one side of the tube to the coupling E-lock system draw-off and the other side to the dosing gun.

Plug the E-lock coupling system to the FlexiBag.

Gently prime the dosing gun, checking before use that all connections are tight.

Follow the gun manufacturer’s instructions for adjusting the dose and proper use and maintenance of the dosing gun.

When body weight is between marking, use the higher setting.

No signs of toxicity have been observed after administration of up to 5 times the recommended dose. No specific antidote has been identified.

Meat and offal: 15 days.

Milk: zero hours.