Cydectin 20 mg/ml LA Solution for Injection for Sheep

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 infestation based on its epidemiological
features, for each individual herd.
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; it has been reported in a single case involving a levamisole-, benzimidazole
and ivermectin-resistant strain of Teladorsagia circumcincta. Therefore, the use of
moxidectin should be based on local (regional, farm) epidemiological information
about susceptibility of nematodes, local history of treatments and recommendations
on how to use the product under sustainable conditions to limit further selection for
resistance to anthelmintics. These precautions are especially important when
moxidectin is being used to control resistant strains.
Trials have shown that moxidectin is effective against certain strains of
Haemonchus contortus, Teladorsagia circumcincta Trichostrongylus .
resistant to benzimidazoles.
Psoroptes ovis is an extremely contagious external parasite of sheep and cattle. To
ensure complete control, great care must be taken to avoid re-infestation, as mites
may be viable for up to 15 days off the animal. It is important that all animals which
have been in contact with infected ones are treated with an appropriate product.
Contact between treated, infected and untreated herds must be avoided until at
least seven days after treatment.
Resistance to moxidectin has been reported in Psoroptes ovis scab mites in sheep
and in cattle. Cases of side-resistance with other macrocyclic lactones (ivermectin
and doramectin) have been reported as well. The use of this product should take
into account local information about susceptibility of the target parasites, where
available.

Special precautions for safe use in the target species:
This product has been formulated specifically for subcutaneous injection in the base
of the ear of sheep 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:
Avoid direct contact with skin and eyes.
Wash hands after use.
Do not smoke, drink or eat while handling the product.
Take care to avoid self-injection. If this occurs, it is unlikely that any product related
symptoms will be observed. In case of accidental self-injection, seek medical
advice immediately and show the package leaflet or the label to the physician.
Advice to Medical Practitioners in case of accidental self-injection: treat
symptomatically.
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 more than 4 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, 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 injectable formulation to sheep,
treated animals should not have access to watercourses during the first 11 days
after treatment.