Rumenil 34 mg/ml Oral Suspension for Cattle

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.
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.
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 spp. and recommendations on how to limit further
selection for resistance to anthelmintics.
AN: 02074/2024 & 02078/2024

Special precautions for safe use in the target species:
When a dosing gun is used to administer the product, care must be taken to
avoid damage to the pharyngeal region.
Adverse effects (see section 3.6) are occasionally enhanced in animals
suffering from severe liver damage and/or dehydration at the time of dosing.
Due regard must always be given to the physical condition of animals
undergoing treatment, particularly those in advanced pregnancy and/or under
stress from adverse weather conditions, poor nutrition, penning, handling etc.
These effects are occasionally enhanced in animals suffering from severe liver
damage and/or dehydration at the time of dosing.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals:
Do not eat, drink or smoke when handling the product.
This veterinary medicinal product can cause irritation to skin, eyes and mucous
membranes. Wear impermeable gloves during use. In case of contact with the
product, rinse the affected area immediately with plenty of water.
Contaminated clothing should be removed immediately.
Wash hands after use.
People with known hypersensitivity to oxyclozanide or any of the excipients
should avoid contact with the veterinary medicinal product.
Special precautions for the protection of the environment:
Oxyclozanide is toxic to dung fauna and aquatic organisms. The risk to aquatic
ecosystems and dung fauna can be reduced by avoiding too frequent and
repeated use of oxyclozanide in cattle. The risk to aquatic ecosystems will be
further reduced by keeping treated cattle away from water bodies for 5 days
after treatment.
AN: 02074/2024 & 02078/2024