Do not use in cases of hypersensitivity to the active substance or to any of the excipients
Special warnings
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 nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use
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 where handling the product.
This veterinary medicinal product can cause irritation to skin, eyes and mucous membranes. 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.
Wear impermeable gloves during 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.
Adverse reactions
Cattle:
Undetermined frequency
(cannot be estimated from the available data)
Loose stool
Diarrhoea
Inappetence 1
Milk production decrease 2
1 Transient
2 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.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Environmental properties
Faeces containing oxyclozanide excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on dung degradation.
Oxyclozanide is toxic to aquatic organisms. Oxyclozanide is persistent in soils.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
The veterinary medicinal product should not enter water courses as Oxyclozanide may be dangerous for fish and other aquatic organisms.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Use during pregnancy, lactation or lay
Can be used during pregnancy or lactation. See section 3.5.
Target animals treated with oxyclozanide at the recommended therapeutic doses in several phases of reproduction showed no evidence of foetotoxicity, teratogenicity or effects on fertility.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
The effects of oxyclozanide overdosage are possible diarrhoea, inappetence and loss of weight in cattle. These effects are occasionally enhanced in animals with severe liver damage and/or dehydration at the time of dosing.
At higher doses the severity of signs of toxicity increased and mortality occurred at 50 mg/kg bw and higher.
Major Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Withdrawal periods
Meat and offal: 13 days.
Milk: 108 hours (4.5 days).