•Do not use in cases of known hypersensitivity to the active ingredient.
• The product has been formulated for topical application specifically for cattle. It should not be administered to other species as severe adverse reactions, including fatalities in dogs, may occur.
Cattle should not be treated when hair or hide is wet. Rain falling on cattle in less than two hours after dosing may result in reduced efficacy. However, the efficacy of the product against established infections of O. ostertagi or D. viviparus is not adversely affected if the hide is wet or if rain falls shortly after treatment.
Do not apply to areas of skin that may have mange scabs or other lesions or to areas contaminated with mud or manure.
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.
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 ivermectin has been reported in Ostertagia ostertagi in cattle. Therefore, the use of this product should be based on local (region, farm) epidemiological information about susceptibility of this helminth species and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use in animals
Ivermectins may not be well tolerated in all non-target species. Cases of intolerance with fatal outcome are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises. To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine, it is recommended to administer the product at the end of the period of warble fly activity and before the larvae reach their resting site. As Ivermectin is extremely dangerous to fish and aquatic life, treated animals should not have direct access to surface water and ditches during treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
The product may be irritating to human skin and eyes and the user should be careful not to apply it to himself or other persons. Operators should wear rubber gloves and boots with a waterproof coat when applying the product. Protective clothing should be washed after use. Use only in well-ventilated areas or outdoors.
Keep away from heat, spark, open flame or other source of ignition. Do not eat, drink or smoke whilst handling the product.
As absorption through skin can occur, in the event of accidental skin contact the affected area should be washed immediately with soap and water.
If accidental eye exposure occurs, flush the eyes immediately with water and seek medical attention. Wash hands after use.
Adverse reactions (frequency and seriousness)
Occasionally slight irritation at the application site may occur. However, usually these irritations rapidly disappear without treatment.
Use during pregnancy, lactation or lay
The product can be used during pregnancy and lactation.
The product will not affect the fertility of cows and bulls and can be given to all ages of animals including young calves.
Interaction with other medicinal products and other forms of interaction
Overdose (symptoms, emergency procedures, antidotes), if necessary
No sign of toxicity appeared up to 1.5 mg/kg (3 times the recommended dose rate).
No antidote has been identified. The signs of overdose can be trembling, convulsions and coma. In case of overdose symptomatic treatment should be given.
Meat and offal: 28 days
Milk: Not permitted for use in lactating cattle producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant dairy heifers within 60 days prior to calving.