Cydectin 1% w/v Solution for Injection 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.
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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
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
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.
A single injection will protect against scab for at least 28 days but contact with
infected sheep after this time may result in infestation. All bought-in or returning
animals should be treated and isolated for at least 12 days.

Special precautions for safe use in the target species:
It is important to treat at the recommended dosage and to avoid under-dosing since
this will result in spread of sheep scab.
Signs of sheep scab can be confused with chewing louse infestation, against which
the product is not effective.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
In case of contact with skin and eyes, wash affected area with clean water.
Do not smoke, eat, or drink while handling the product.
Wash hands after use.
To the physician:
In cases of accidental self-injection, treat any specific signs 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.