Eprecis 20 mg/ml Solution for Injection for Cattle, Sheep and Goats

Cattle, sheep and goats
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 product should be based on confirmation of the parasitic
species and burden, or of the risk of based on its epidemiological features, for each
herd/flock.
Repeated use for an extended period, particularly when using the same class of
substances, increases the risk of resistance development. Within a herd/flock,
maintenance of susceptible refugia is essential to reduce that risk. Systematically
applied interval-based treatment and treatment of a whole herd/flock 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/flock 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.
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.
Cattle
Resistance to other macrocyclic lactones has been reported in parasite species in
cattle within the EU. 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.
Sheep and goats
Resistance to eprinomectin in parasite species in goats and sheep has been reported
within the EU. 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.

Special precautions for safe use in the target species
Usual aseptic procedures for administration of a parenteral injection should be
followed.
The death of warble fly larvae in the oesophagus or spinal cord canal may lead to
secondary reactions. In order to avoid secondary reactions due to the death of
Hypoderma larvae in the oesophagus or the spine, it is recommended to administer
the veterinary medicinal product at the end of the period of fly activity and before the
larvae reach their resting site.
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
The veterinary medicinal product causes serious eye irritation. Avoid contact with the
eyes. Wash any splashes from eyes immediately with water.
This veterinary medicinal product may cause neurotoxicity. Care should be taken
when handling the veterinary medicinal product to avoid self-injection. In case of
accidental injection, seek medical advice immediately and show the package leaflet
or the label to the physician.
Avoid contact with the skin. Wash any splashes from skin immediately with water.
Avoid oral exposure. Do not eat, drink or smoke while handling the veterinary
medicinal product.
Wash hands after use.
The excipient glycerol formal may cause harm to the unborn child. In addition, the
active substance eprinomectin can be transferred to breast milk. Pregnant/breast-
feeding women and women of childbearing age should therefore avoid exposure to
this veterinary medicinal product.
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 too
frequent and repeated use of eprinomectin (and products of the same anthelmintic
class) in cattle, sheep and goats.
The risk to aquatic ecosystems will be further reduced by keeping treated cattle,
sheep and goats away from water bodies for two to five weeks after treatment.