Cydectin TriclaMox 1 mg/ml + 50 mg/ml Oral Solution for Sheep

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:
•
extended period of time.
•
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.
Resistance to macrocyclic lactones has been reported in Teladorsagia in sheep in a
number of countries. In 2008, throughout Europe, moxidectin resistance is very rare.
Resistance to triclabendazole has been reported in Fasciola hepatica in sheep in
some European countries. Therefore the use of this product should be based on local
(regional, farm) epidemiological information about susceptibility of parasites, local
history of treatments and recommendations on how to use the product under
sustainable conditions to limit further selection for resistance to antiparasitic
compounds. These precautions are especially important when moxidectin is being
used to control resistant strains.

Special precautions for safe use in the target species:
This product should not be used for the treatment of single infections.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
People with known hypersensitivity to the active substance should avoid contact with
the veterinary medicinal product.
Avoid direct contact with skin and eyes.
Wash hands after use.
Do not smoke, drink or eat when using this product.
Personal protective equipment consisting of impermeable gloves should be worn
when handling the veterinary medicinal product.
Special precautions for the protection of the environment:
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT)
substance; therefore, exposure of the environment to moxidectin must be limited to
the extent possible. Treatments should be administered only when necessary and
should be based on faecal egg counts or evaluation of the risk of infestation at the
animal and/or herd level.
Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-
target organisms:
•
temporarily reduce the abundance of dung feeding organisms. Following
treatment of sheep with the product, levels of moxidectin that are potentially
toxic to dung fly species may be excreted over a period of 4 days and may
decrease dung fly abundance during that period. It has been established in
laboratory tests that moxidectin may temporarily affect dung beetle
reproduction; however, studies with incurred residues indicate no long-term
effects. Nevertheless, in case of repeated treatments with moxidectin (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.
•
should be used only according to the label instructions. Based on the excretion
profile of moxidectin when administered as the oral formulation to sheep,
treated animals should not have access to watercourses during the first 3 days
after treatment.