Contraindications:
The product is formulated only for topical application for 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 known cases of hypersensitivity to the active substance or to any of the excipients.
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.
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 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, eat or drink 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.
Special warnings for each target species
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.
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 programme to control both internal and external parasites of cattle based on the epidemiology of these
parasites.
Use during pregnancy and lactation
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 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No signs of toxicity appeared when 8-week old calves were treated at up to 5 times the therapeutic dose (2.5 mg Eprinomectin/kg body weight) 3 times at 7-day intervals. One calf treated once at 10 times the therapeutic dose (5 mg/kg body weight) in the tolerance study showed transient mydriasis. There were no other adverse reactions to treatment. No antidote has been identified.
Other precautions
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 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 three weeks after treatment.
Withdrawal period
Meat and Offal: 15 days
Milk: Zero hours
Adverse reactions (frequency and seriousness)
Pruritus and alopecia have been observed after the use of the veterinary medicinal product in very rare cases.
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).