Cydectin TriclaMox 5 mg/ml + 200 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 body weight, 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 moxidectin has been reported mainly in Cooperia oncophora in some
European countries.Resistance to other MLs in some strains of Cooperia spp. can imply
concurrent resistance to Moxidectin. Resistance to triclabendazole has been reported in
Fasciola hepatica in cattle in some European countries. Triclabendazole resistant F.
hepatica hosted in sheep can be transferred to cattle grazing the same pasture. 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 limit further selection for resistance to anthelmintics.
This veterinary medicinal product should not be used for the treatment of single infections.
It has been shown that rainfall immediately before or within 2 hours after treatment will not
affect the efficacy of the product.

Special precautions for safe use in the target species:
This product has been formulated specifically for pour-on administration for cattle and
must not be given by any other route of administration or to any other species.
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. The veterinary medicinal product may cause skin and eye
irritationAvoid direct contact with skin and eyes.
Personal protective equipment consisting of gloves, protective work clothing and safety
glasses should be worn when handling the veterinary medicinal product. In case of
accidental splash onto the eye or the skin, wash with plenty of clean, running water
immediately.
If irritation persists, seek medical advice immediately and show the package leaflet or the
label to the physician.
Do not smoke, drink or eat while handling the product. Wash hands after use.
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
cattle with the product, levels of moxidectin that are potentially toxic to dung fly
species may be excreted over a period more than 2 weeks 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, field studies
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.
•
be used only according to the label instructions. Based on the excretion profile of
moxidectin when administered as the pour-on formulation, treated animals should not
have access to watercourses during the first week after treatment.