Cydectin 0.1% w/v Oral Solution 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
veterinary medicinal product should be based on confirmation of the parasitic species and
burden, or of the risk of
infection based on its epidemiological features, for each flock.
Repeated use for an extended period, particularly when using the same class of
substances,
increases the risk of resistance development. Within a flock, maintenance of susceptible
refugia is essential to reduce that risk. Systematically applied interval-based treatment and
treatment of a whole 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 flock should be sought from the responsible veterinarian.
Multiple resistance of Teladorsagia circumcincta
and ivermectin was reported throughout Europe. Moxidectin-resistant Haemonchus
contortus and were also described. Therefore, the use of
this veterinary medicinal product should take into account local information about
susceptibility of the target parasites, where available. Additionally, use should be based on
local history of treatments and recommendations on how to use the veterinary medicinal
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.
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Clinical trials, after experimental and natural infection, have shown that the veterinary
medicinal product is effective against certain benzimidazole resistant strains of:
. Haemonchus contortus
. Ostertagia circumcincta
. Trichostrongylus colubriformis
. Cooperia curticei
It is recommended to further investigate cases of suspected resistance, using an
appropriate
diagnostic method (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.

Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the medicinal products to
animals:




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
flock 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 veterinary medicinal 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 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.
•
medicinal product should be used only according to the label instructions. Based on
the excretion profile of moxidectin when administered as the oral formulation to
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sheep, treated animals should not have access to watercourses during the first
3 days after treatment.