Distocur 34 mg/ml Oral Suspension for Cattle and Sheep

To date no resistance to oxyclozanide has been reported. Use of the product should
be based on local (regional, farm) epidemiological information about susceptibility of
Fasciola hepatica and recommendations on how to limit further selection for
resistance to anthelmintics.
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 pharmaceutical class and having a different mode of action
should be used.
At normal dose levels, oxyclozanide is not active against immature flukes present in
liver tissue.
Milking cattle, particularly high yielders, may show a reduction in yield, occasionally of
5 % or more, for about 48 hours after handling. The effect of this small loss may be
minimised by spreading herd dosing over a period of about one week.

Special precautions for safe use in the target species:
To avoid injuries of the pharyngeal region, care should be taken when administering
the veterinary medicinal product by dosing gun.
Adverse events (see section 3.6) are occasionally enhanced in animals suffering
from severe impairment of liver function and/or dehydration at the time of dosing.
The physical condition of animals undergoing treatment should always be observed,
particularly of those in advanced pregnancy and/or under stress from adverse
weather conditions, poor nutrition, penning, handling, etc.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
The veterinary medicinal product may cause irritation to skin, eyes and mucous
membranes.
People with known hypersensitivity to oxyclozanide or any of the excipients should
avoid contact with the veterinary medicinal product.
Wash hands after use.
Operators should wear impermeable rubber gloves when applying the veterinary
medicinal product.
Do not smoke, eat or drink while handling the veterinary medicinal product.
In case of contact with the veterinary medicinal product, rinse the affected area
immediately with plenty of water.
Contaminated clothing should be removed immediately.
In the event of accidental ingestion, seek medical advice immediately and show the
package leaflet or label to the physician.
Special precautions for the protection of the environment:
Oxyclozanide is toxic to dung fauna. The risk can be reduced by avoiding too
frequent and repeated use of oxyclozanide in cattle.