Neoprinil Pour-on 5 mg/ml Pour-on Solution for Cattle

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 veterinary medicinal 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 in
cattle within the EU. However 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.
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 veterinary medicinal product should be part of a planned
programme to control both internal and external parasites of cattle based on the
epidemiology of these parasites.

Special precautions for safe use in the target species:
For external use only.
To avoid adverse reactions due to the death of warble larvae in the oesophagus or
backbone, it is recommended to administer the veterinary medicinal product after the
end of the swarming of the warbles and before the larvae reach their sites in the
body; consult a veterinary surgeon to know the appropriate treatment period.
For effective use, the veterinary medicinal product should not be applied to areas of
the backline covered with mud or manure. The veterinary medicinal product should
be applied only on healthy skin.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
This veterinary medicinal product may be irritating to the skin and eyes and may
cause hypersensitivity (allergic reactions).
Avoid direct contact with the skin or eyes during treatment and when handling
recently treated animals.
People with known hypersensitivity to eprinomectin should avoid contact with the
veterinary medicinal product.
Personal protective equipment consisting of rubber gloves, boots and a waterproof
coat should be worn 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.
Should clothing become contaminated, remove as soon as possible and launder
before re-use. 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. In case of accidental ingestion, wash
the mouth out 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 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 veterinary
medicinal 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.