Do not administer by the intravenous or intramuscular route.
Do not use in cases of hypersensitivity to the active ingredient or to any of excipients.
Do not use in dogs or cats as severe adverse reactions may occur.
Special warnings
In sheep treatment of psoroptic mange (sheep scab) with one injection is not recommended because, although a clinical improvement may be seen, elimination of all mites may not occur.
Sheep scab (Psoroptes ovis) is an extremely contagious external parasite of sheep. To ensure complete control 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 that all sheep which have been in contact with infected sheep are treated. Contact between treated, infected and untreated flocks must be avoided until at least seven days after treatment.
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each herd or flock.
Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a herd or flock, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole herd or flock should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific herd/flock should be sought from the responsible veterinarian.
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.
In sheep, resistance to ivermectin is widespread in Teladorsagia circumcincta, Trichostrongylus spp., Haemonchus contortus and in other gastro-intestinal parasite species.
Multiple resistance was reported in Teladorsagia circumcincta to benzimidazoles, macrocyclic lactones and levamisole and in Haemonchus contortus to ivermectin and benzimidazoles.
Multiple resistance to macrocyclic lactones has also been reported in Psoroptes ovis scab mites in sheep and in cattle.
The use of this product should take into account local information about susceptibility of the target parasites, where available. It is recommended to further investigate cases of suspected resistance, using an appropriate diagnostic method (e.g. Faecal Egg Count Reduction Test). Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.
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
'This product may cause eye and skin irritation. Avoid contact with skin or eyes. In case of skin or eye contact, wash exposed area with plenty of clean water. If symptoms persist, seek medical advice.
Take care to avoid accidental self-injection: the product may cause local irritation and/or pain at the site of injection. In case of accidental self-injection, seek immediate medical advice and show the information leaflet or the label to the physician.
Do not eat or smoke while handling the product.
Wash hands after use.
Other precautions
The product is very toxic to aquatic organisms and dung insects.
Long term effects on dung insects caused by continuous or repeated use cannot be excluded therefore repeated treatment of animals on a pasture with an ivermectin-containing product within a season should only be given in the absence of alternative treatments or approaches to maintain animal/flock health, as advised by a veterinarian.
Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment.
Adverse reactions (frequency and seriousness)
Cattle
Transitory discomfort has been observed in some cattle. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment.
Pigs
Mild and transient pain reactions may be seen in some pigs.
All these reactions disappeared without treatment.
Sheep
Immediately following subcutaneous injection, activity suggesting pain, sometimes intense but usually transient, has been observed in some sheep.
Use during pregnancy, lactation or lay
The product can be administered during pregnancy and lactation in cows, ewes and sows. The product does not affect fertility. It can be used in breeding cows and bulls, breeding ewes and rams, in sows and boars.
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.
Major Incompatibilities
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.
Cattle
Single doses of 4.0 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.
Pigs
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.
Sheep
At dose levels up to 4 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.
No antidote has been identified; however, symptomatic therapy may be beneficial.
Withdrawal Period(s)
Cattle
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.
Pigs
Meat and offal: 28 days.
Sheep
Meat and offal: 25 days
Do not use in lactating sheep producing milk for human consumption.
Do not use in sheep within 60 days of lambing where milk is to be used for human consumption