Target species
Cattle (beef and dairy cattle)
Indications for use, specifying the target species
Indicated for the treatment and prevention of the following parasites.
Gastrointestinal Roundworms (adults and fourth stage larvae):
Ostertagia spp., Ostertagia lyrata (adult), Ostertagia ostertagi (including inhibited O. ostertagi), Cooperia spp. (including inhibited Cooperia spp), Cooperia oncophora, Cooperia pectinata, Cooperia punctata, Cooperia surnabada, Haemonchus placei, Trichostrongylus spp., Trichostrongylus axei, Trichostrongylus colubriformis, Bunostomum phlebotomum, Nematodirus helvetianus, Oesophagostomum spp. (adult), Oesophagostomum radiatum, Trichuris spp (adult).
Lungworms (adults and fourth stage larvae):
Dictyocaulus viviparus
Warbles (parasitic stages):
Hypoderma bovis, H. lineatum
Mange Mites:
Chorioptes bovis, Sarcoptes scabiei var bovis
Lice:
Damalinia (Bovicola) bovis (biting lice), Linognathus vituli (sucking lice), Haematopinus eurysternus (sucking lice), Solenopotes capillatus (sucking lice).
Horn Flies:
Haematobia irritans.
Prolonged Activity
Applied as recommended, the product prevents reinfections with:
Parasite * | Prolonged Activity |
Dictyocaulus viviparus | up to 28 days |
Ostertagia spp | up to 28 days |
Oesophagostomum radiatum | up to 28 days |
Cooperia spp | up to 21 days |
Trichostrongylus spp | up to 21 days |
Haemonchus placei | up to 14 days |
Nematodirus helvetianus | up to 14 days |
*The following parasite species are included within each of the relevant genera: Ostertagia ostertagi, O. lyrata, Cooperia oncophora, C. punctata, C. surnabada, Trichostronglus axei, T. colubroformis.
Contraindications
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 cases of hypersensitivity to the active substance(s) or to any of the excipient(s).
Special Warnings for each target species
If there is a risk for re-infestation, the advice of a veterinarian should besought regarding the need for and frequency of repeat administration.
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.
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.
For effective use, the product should not be applied to areas of the backline covered with mud or manure.
For the best results the product should be part of a program to control both internal and external parasites of cattle based on the epidemiology of these parasites.
Special precautions for use
Special precautions for use in animals
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 product should be applied only to 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 product at the end of warble fly activity and before the larvae reach their resting sites.
Rainfall at any time before or after treatment will not affect the efficacy of the product.
Special precautions to be taken by the person administering the veterinary medicinal product to animals.
This product may be irritating to human skin and eyes and may cause hypersensitivity.
Avoid skin and eye contact with the product during treatment and when handling recently treated animals.
Users should wear rubber gloves, boots and a waterproof coat when applying the product.
Should clothing become contaminated, remove as soon as possible and launder before re-use.
If accidental skin contact occurs, wash the affected area immediately with soap and water.
If accidental eye exposure occurs, flush eyes immediately with water.
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 ingestion, wash out mouth with water and seek medical advice.
Wash hands after use.
This product is flammable. Keep away from sources of ignition.
Inhalation of the product may cause irritation.
Use only in well ventilated areas or outdoors.
Other precautions
Eprinomectin is very toxic to dung fauna and aquatic organisms 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 four weeks after treatment.
Adverse reactions (frequency and seriousness)
In very rare cases application site reactions (i.e. alopecia) have been reported after the use of the veterinary medicinal product.
The frequency of adverse reactions is defined using the following convention:
•very common (more than 1 in 10 animals treated displaying adverse reaction(s))
•common (more than 1 but less than 10 animals in 100 animals treated)
•uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
•rare (more than 1 but less than 10 animals in 10,000 animals treated)
•very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
May be used in dairy cattle during all stages of lactation.
Studies conducted at three times the recommended use level of 0.5 mg eprinomectin/kg b.w. had no adverse effect on breeding performance of cows or bulls.
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.
Amounts to be administered and administration route
Administer only by topical application at the dose rate of 1 ml per 10 kg of body weight, corresponding to the recommended dose rate of 0.5 mg eprinomectin per kg b.w. The product should be applied topically by pouring along the backline in a narrow strip extending from the withers to the tailhead.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device (dosing cup or dosing gun delivery system) should be checked.
For external use. Pour-on use”
All the animals belonging to the same group should be treated at the same time.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In adult cattle, after administration of 5 times the recommended dose (2.5 mg eprinomectin/kg body weight), mild hair loss was observed. No other signs of toxicity were seen.
No antidote has been identified.
Withdrawal period(s)
Meat & offal: 10 days
Milk: zero hours.