Do not use in lactating dairy cows or sheep producing milk for human consumption. Do not use in non-lactating dairy cows, including pregnant dairy heifers, within 60 days of calving. Do not use in sheep which are intended to produce milk for human consumption within 60 days of lambing.
Do not use in cases of known hypersensitivity to ivermectin.
Do not administer by the intravenous or intramuscular route.
Special warnings for each target species
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 bodyweight, 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.
Treatment of psoroptic mange (sheep scab) with one injection is not recommended because, although clinical improvement may be seen, elimination of all mites may not occur.
Sheep scab (Psoroptes ovis) is an extremely contagious external parasite of sheep. Following treatment of infected sheep great care must be taken to avoid re-infestation as mites may be viable for up to 15 days off the sheep. It is important to ensure all sheep which have been in contact with infected sheep are treated. Contact between treated infected and non-treated, non-infected flocks must be avoided until at least 7 days after the last treatment.
Resistance to ivermectin has been reported in Ostertagia circumcincta in lambs and in Ostertagia ostertagi in cattle. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of these helminth species and recommendations on how to limit further selection for resistance to anthelmintics
Special precautions for use in animals
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.
Do not combine treatment with vaccination against lungworms. If vaccinated animals are to be treated, treatment should not be carried out within a period of 28 days before or after vaccination.
The shedding of nematode eggs can continue for some time after treatment.
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.
Swab septum before removing each dose.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not smoke, eat or drink while handling the product.
Wash hands after use.
Take care to avoid self injection: the product may cause local irritation and/or pain at the site of injection.
Adverse reactions (frequency and seriousness)
Transitory discomfort has been observed in some animals immediately following subcutaneous administration. In cattle this may include jumping and rolling, but behaviour returns to normal after 15 minutes.
Soft tissue swelling and thickening of the skin at the injection site has been observed in treated animals. Typically these reactions are transient and disappear within one to four weeks
Use during pregnancy, lactation or lay
The product can be administered during pregnancy in cows, ewes and sows (for section on use in lactating animals).
The fertility of males is not affected by administration of the product.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.