Eprinex Multi 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
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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 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 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. The use of this veterinary medicinal product should
take into account local information about susceptibility of the target parasites, where
available.
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 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.
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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. Avoid contact with
eyes and skin.
Personal protective equipment consisting of rubber gloves, boots and 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 skin contact, wash the affected area immediately with soap and
water.
In case of accidental eye exposure, flush eyes immediately with plenty of clean water.
Should irritation persist, seek medical advice and show the package leaflet or the label
to the physician.
Do not ingest.
In case of accidental ingestion, rinse out mouth thoroughly with water, seek medical
advice immediately and show the package leaflet or the label to the physician.
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 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.