Target species
Cattle.
Indications for use, specifying the target species
Treatment of infestations by the following internal and external parasites sensitive to eprinomectin:
Adult
L4
Inhibited L4
Gastrointestinal roundworms
Ostertagia ostertagi
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Ostertagia lyrata
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Ostertagia spp.
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Cooperia oncophora
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Cooperia pectinata
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Cooperia surnabada
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Cooperia punctata
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Cooperia spp.
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Haemonchus placei
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Trichostrongylus axei
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Trichostrongylus colubriformis
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Trichostrongylus spp.
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Bunostomun phlebotomum
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Nematodirus helvetianus
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Oesophagostomum radiatum
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Oesophagostomum spp.
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Trichuris spp.
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Lungworms
Dictyocaulus viviparus
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Sucking lice: Haematopinus eurysternus, Linognathus vituli, Solenopotes capillatus
Horn flies: Haematobia irritans
Warbles (parasitic stages): Hypoderma bovis, Hypoderma lineatum
Mange mites: Sarcoptes scabiei var. bovis
Prevention of reinfestations:
The product protects treated animals against reinfestations with:
-Trichostrongylus spp. (including Trichostrongylus axei and Trichostrongylus colubriformis), Haemonchus placei, Cooperia spp. (including Cooperia oncophora, Cooperia punctata, Cooperia surnabada), Dictyocaulus viviparus, Oesophagostomum radiatum, Ostertagia spp. (including Ostertagia ostertagi and Ostertagia lyrata) and Nematodirus helvetianus for 14 days.
-Haematobia irritans for at least 7 days.
Contraindications
Do not use in other animal species.
Do not use in case of hypersensitivity to active substance or to any of the excipients.
Special warnings
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 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.
Special precautions for use
Special precautions for use in animals
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.
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 warble fly activity and before the larvae reach their resting sites in the body; consult a veterinary surgeon regarding the appropriate time for treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
Do not use the product in known cases of sensitivity to the active substance or to any of the excipients.
Other precautions
Eprinomectin is very toxic to 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.
The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Adverse reactions (frequency and seriousness)
Following treatment, moderate to severe swelling at the site of injection is very common. Typically, the swelling resolves within 7 days, but induration (hardness) may persist for in excess of 21 days. Swelling may be associated with mild to moderate pain.
This reaction disappears without any treatment and does not impair the safety or efficacy of the veterinary medicinal product.
Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
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.
