This veterinary medical product is formulated only for topical application for beef and dairy cattle, including lactating dairy cattle.
Do not administer orally or by injection.
Do not use in other animal species.
Do not use in cases of hypersensitivity to the active substance or to any of the excipient(s).
Special warnings for each target species
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.
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 body weight, 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 in animals
For external use only. 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.
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
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. Do not smoke or eat while handling the veterinary medicinal product. Wash hands after use. Should clothing become contaminated, remove as soon as possible and launder before re-use. In the event of ingestion, wash out mouth with water and seek medical advice. 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. 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.
No undesirable effects have been identified when the product is used at the recommended dose rate.
Use during pregnancy, lactation or lay
Laboratory studies (rat, rabbit) have not produced any evidence of teratogenic or embryotoxic effects due to the use of eprinomectin at therapeutic doses. The safety of eprinomectin 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.
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.
No signs of toxicity appeared when 8-week old calves were treated at up to 5x the therapeutic dose (2.5 mg Eprinomectin/kg b.w.) 3 times at 7-day intervals. One calf treated once at 10x the therapeutic dose (5 mg/kg b.w.) in the tolerance study showed transient mydriasis. There were no other adverse reactions to treatment. No antidote has been identified.
Meat and offal: 15 days
Milk: zero hours.
Like other macrocyclic lactones, eprinomectin has the potential to adversely affect non-target organisms. Following treatment, excretion of potentially toxic levels of eprinomectin may take place over a period of several weeks.
Faeces containing eprinomectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may accumulate in sediments.