Target species
Cattle (beef and dairy cattle).
Indications for use for each target species
Indicated for treatment and control of the following parasites:
Gastrointestinal Roundworms (Adult, L4 and Inhibited L4)
Ostertagia ostertagi
Cooperia spp.
Gastrointestinal Roundworms (Adult and L4)
Ostertagia spp.
Cooperia oncophora
Cooperia pectinata
Cooperia punctata
Cooperia surnabada
Haemonchus placei
Trichostongylus spp.
Trichostrongylus axei
Trichostrongylus colubriformis
Bunostomum phlebotomum
Nematodirus helvetianus
Oesophagostomum radiatum
Gastrointestinal roundworms (Adult)
Ostertagia lyrata
Oesophagostomum spp.
Trichuris spp.
Lungworms (Adult and L4)
Dictyocaulus viviparus
Warbles (parasitic stages)
Hypoderma bovis
H. lineatum
Mange mites
Chorioptes bovis
Sarcoptes scabiei
Lice
Damalinia bovis (biting lice)
Linognathus vituli (sucking lice)
Haematopinus eurysternus (sucking lice)
Solenopotes capillatus (sucking lice)
Prolonged Activity:
Applied as recommended, the veterinary medicinal product controls reinfections with Dictyocaulus viviparus, Ostertagia spp. and Oesophagostomum radiatum for up to 28 days, Cooperia spp. and Trichostrongylus spp. for up to 21 days, and Haemonchus placei and Nematodirus helvetianus for up to 14 days. The following species are included within each of the relevant genera: Ostertagia ostertagi, O. lyrata, Cooperia oncophora, C. punctata, C. surnabada, Trichostrongylus axei, T. colubriformis.
For best results the veterinary medicinal product should be part of a programme to control both internal and external parasites of cattle based on the epidemiology of these parasites.
Contraindications
This veterinary medicinal product is formulated only for topical application to beef and dairy cattle, including lactating dairy cattle. Do not use in other animal species. Avermectins can cause fatalities in dogs, especially collies, old English sheepdogs and related breeds and crosses, and also in turtles/tortoises.
Do not administer orally or by injection. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
For effective use, the veterinary medicinal product should not be applied to areas of the backline covered with mud or manure.
Unnecessary use of antiparasitic or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each herd.
Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a herd, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole herd should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific herd should be sought from the responsible veterinarian.
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. Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.
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 nematode populations in cattle within the EU, which may be associated with side-resistance to eprinomectin. The use of this veterinary medicinal product should take into account local information about susceptibility of target parasites, where applicable.
While mite and louse numbers decline rapidly following treatment, due to the feeding habits of the parasites, in some cases several weeks may be required for complete eradication.
Special precautions for safe use in the target species:
For external use only. The veterinary medicinal product should be applied only on healthy skin.
To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine, it is recommended to administer the veterinary medicinal product at the end of warble fly activity and before the larvae reach their resting sites.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
∙ People with known hypersensitivity to eprinomectin or to any of the excipients should avoid contact with the veterinary medicinal product.
∙ This veterinary medicinal product may be irritating to skin and eyes and may cause hypersensitivity.
∙ Avoid skin and eye contact with the veterinary medicinal product during treatment and when handling recently treated animals.
∙ Personal protective equipment consisting of rubber gloves, boots and a waterproof coat should be worn when handling the veterinary medicinal product.
∙ Should clothing become contaminated, remove as soon as possible and launder before re-use.
∙ In case of accidental spillage onto skin, wash the affected area immediately with soap and water and water, and seek medical advice immediately and show the package leaflet or the label to the physician.
∙ In case of accidental eye exposure, flush eyes immediately with water, and seek medical advice show the package leaflet or the label to the physician.
∙ This product may be toxic after accidental ingestion. Avoid accidental ingestion of the product by hand to mouth contact.
∙ Do not smoke, eat or drink while handling the product.
∙ In the event of accidental ingestion, wash out mouth with water and seek medical advice immediately and show the package leaflet or the label to the physician.
∙ Wash hands after use.
Other precautions for the protection of the environment:
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 repeated use of eprinomectin (and products of the same anthelmintic class).
In order to reduce the risk to aquatic ecosystems, treated animals should not have direct access to water bodies for two to five weeks after treatment.
Adverse events
Very rare (<1 animal / 10,000 animals treated, including isolated reports): Pruritus, alopecia.
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
Can be used during pregnancy. Studies have demonstrated a wide safety margin. Studies conducted at three times the recommended use level of 0.5 mg/kg bodyweight of eprinomectin had no adverse effect on breeding performance of cows or bulls.
Lactation:
May be used in dairy cattle during all stages of lactation.
Interaction with other medicinal products and other forms of interaction
No interactions with other medicines and no other forms of interactions are known. Since eprinomectin binds extensively to plasma proteins, this should be taken into account if it is used in association with other molecules having the same characteristics.
Administration routes and dosage
Pour-on use. For single application only.
To ensure a correct dosage, bodyweight should be determined as accurately as possible. The use of suitably calibrated measuring equipment is recommended. If animals are to be treated collectively rather than individually, reasonable homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one. Underdosing could result in ineffective use and may favour resistance development.
Dosage:
Administer only by topical application at the dose rate of 1 ml per 10 kg of bodyweight, corresponding to the recommended dose rate of 0.5 mg eprinomectin per kg bodyweight.
Method of administration:
The veterinary medicinal product should be applied topically by pouring along the backline in a narrow strip extending from the withers to the tailhead.
For 250 ml and 1 litre bottles:
Attach the dose dispenser to the bottle. Set the dose by turning the top section of the dose dispenser to align the correct bodyweight with the pointer inside the dose dispenser. When bodyweight is between markings, 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. Tilt the bottle to deliver the dose. For the 1 litre bottle: when a 10 ml or 15 ml dose is required, turn the pointer to ‘’STOP’’ before delivering the dose. The off (STOP) position will close the system between dosing.
The dose dispenser should not be stored attached to the bottle when not in use. Remove the dose dispenser after each use and replace with the bottle cap.
For 2.5 and 5 litre backpacks:
Connect the dosing gun and draw-off tubing to the backpack as follows:
Attach the open end of the draw-off tubing to an appropriate dosing gun. Attach draw-off tubing to the cap with the stem that is included in the pack. Replace shipping cap with the cap with the draw-off tubing. Tighten the draw-off cap. Gently prime the dosing gun, checking for leaks.
Follow the dosing gun manufacturer’s directions for adjusting the dose and proper use and maintenance of the dosing gun and draw-off tubing.
Overdose
No signs of toxicity appeared when 8-week-old calves were treated at up to 5 times the therapeutic dose (2.5 mg/kg bodyweight eprinomectin) 3 times at 7-day intervals. One calf treated once at 10 times the therapeutic dose (5 mg/kg bodyweight) in the tolerance study showed transient mydriasis. There were no other adverse reactions to treatment. No antidote has been identified.
Withdrawal periods
Meat and offal: 15 days.
Milk: zero hours.