Do not administer by the intravenous or intramuscular route.
Do not use in animals with known hypersensitivity to the active ingredient.
Do not use in dogs or cats as severe adverse reactions may occur.
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 Cooperia spp. and in Ostertagia ostertagi in cattle. Resistance has also been reported in Haemonchus contortus in cattle outside the EU. Therefore, the use of this product should be based on local (regional, 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
In cattle, 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 warble fly activity and before the larvae reach their resting sites. Consult your veterinarian on the correct timing of treatment.
Avermectins may not be well tolerated in non-target species. Cases of intolerance with fatal results are reported in dogs – especially Collies, Old English Sheepdogs and related breeds and crosses, and also in turtles/tortoises. In addition, care should be taken to avoid ingestion of spilled product or access to used containers by these other species.
Since ivermectin is highly bound to plasma proteins, special care should be taken in cases of sick animals or in nutritional conditions associated with low plasma protein levels.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
The product may cause local irritation and/or pain at the site of injection. Direct contact of the product with the skin should be avoided. Take care to avoid self administration.
Do not smoke or eat while handling the product.
Wash hands after use. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
The product is very toxic to aquatic organisms and dung insects.
Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment.
Long term effects on dung insects caused by continuous or repeated use cannot be excluded therefore repeat treatments on a pasture within a season should only be given on the advice of a veterinarian.
Adverse reactions (frequency and seriousness)
Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment.
Mild and transient pain reactions may be seen in some pigs following subcutaneous injection.
All these reactions disappeared without treatment.
Use during pregnancy, lactation or lay
The product can be administered during pregnancy and lactation in cows and sows. It can be used in breeding sows and boars and will not affect fertility.
Interaction with other medicinal products and other forms of interaction
Do not combine with vaccination against lungworm. If vaccinated animals are to be treated, treatment should not be carried out within a period of 28 days before or after vaccination.
In the absence of incompatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In the case of overdose a symptomatic treatment should be given.
Single doses of 4.0 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.
A dose of 30 mg ivermectin per kg (100 x the recommended dose of 0.3 mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbency.
Meat and offal: 49 days.
Do not use in lactating cows producing milk for human consumption. Do not use in cattle producing milk for human consumption or in dairy cows within 60 days prior to calving.
Meat and offal: 28 days.