Elivec 5 mg/ml Pour-on Solution for Cattle, Sheep and Goats

For effective use, the veterinary medicinal product should not be applied to areas of
the backline covered with mud or manure.
In cattle, rainfall before, during or after the application of the veterinary medicinal
product, has been shown to have no impact on its efficacy. It also has been
demonstrated that haircoat length has no impact on the veterinary medicinal
product’s efficacy. The effect of rainfall and haircoat length on efficacy has not been
evaluated in sheep and goats.
In order to limit cross-transfer of eprinomectin, treated animals should preferably be
separated from untreated animals. Non-compliance with this recommendation may
lead to residue violations in untreated animals and development of resistance to
eprinomectin.
Unnecessary use of antiparasitics 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.
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.
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 in
cattle while resistance to eprinomectin has been reported in goats and sheep within
the EU. However, resistance to other macrocyclic lactones has been reported in
nematode populations in cattle, sheep and goats within the EU, which may be
associated with side-resistance to eprinomectin.
Therefore, use of this veterinary medicinal 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.
Confirmed resistance should be reported to the marketing authorisation holder or to
the competent authorities.
While mite and louse numbers decline rapidly following treatment, due to the feeding
habits of some mites, 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 larvae in the
oesophagus or backbone, it is recommended to administer the veterinary medicinal
product after the end of warble fly activity and before the larvae reach their resting
sites in the body; consult a veterinary surgeon to know the appropriate treatment
period.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
People with known hypersensitivity to the active substance or to any of the excipients
should avoid contact with the veterinary medicinal product.
Eprinomectin can be transferred to breast milk. Therefore, breast-feeding users
should handle the veterinary medicinal product with great care.
This veterinary medicinal product may be irritating to the skin and eyes. Avoid
contact with the skin and eyes 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.
If accidental skin contact occurs, wash the affected area immediately with soap and
water.
If accidental eye exposure occurs, flush the eyes immediately with water. Should
irritation persist, seek medical advice.
This veterinary medicinal product may affect the central nervous system if
accidentally ingested. Avoid accidental ingestion of the veterinary medicinal product,
including by hand to mouth contact. If ingestion does occur, wash the mouth out with
water and seek medical advice.
Do not smoke, eat or drink while handling the veterinary medicinal product.
Wash hands after use.
Special precautions for the protection of the environment:
Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may
accumulate in sediments.
Faeces containing eprinomectin excreted onto pasture by treated animals may
temporarily reduce the abundance of dung feeding organisms. Following treatment of
cattle with the veterinary medicinal product, levels of eprinomectin that are potentially
toxic to dung fly species may be excreted over a period of more than 4 weeks and
may decrease dung fly abundance during that period.
In case of repeated treatments with eprinomectin (as with products of the same
anthelmintic class) it is advisable not to treat animals every time on the same pasture
to allow dung fauna populations to recover.
Eprinomectin is inherently toxic to aquatic organisms. The veterinary medicinal
product should be used only according to the label instructions. Based on the
excretion profile of eprinomectin when administered as the pour-on formulation,
treated animals should not have access to watercourses during the first 7 days after
treatment.