Before use
Do not use:
- in case of hypersensitivity to the active substance or to any of the excipients.
- in dogs or cats as severe adverse reactions may occur.
Special warnings:
- Some horses with heavy infections of Onchocerca spp. microfilariae have experienced oedema and pruritus following treatment, such reactions are assumed to be the result of death of large numbers of microfilariae. These signs resolve within a few days, but symptomatic treatment may be advisable.
- 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 or misadministration of the veterinary medicinal product.
- 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 Parascaris equorum. Therefore, the use of this veterinary medicinal product should be based on local farm epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
- Veterinary advice should be given on appropriate dosing programs and stock management to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance developing.
- In the event that a veterinary medicinal product is suspected of being ineffective, the animal owner is advised to seek veterinary advice.
Special precautions for use in horses: 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.
Other animals: The veterinary medicinal product has been formulated for use in horses only. Cats, dogs (especially Collies, Old English Sheepdogs and related breeds or crosses) and also turtles and tortoises may be adversely affected by the concentration of ivermectin in this veterinary medicinal product if they are allowed to ingest spilled paste or have access to used syringes. Dogs and cats should not be allowed to ingest spilled paste or have access to used packaging due to the potential for adverse effects related to ivermectin toxicity.
Precautions for the person giving the paste:
- Do not smoke, eat or drink while handling the veterinary medicinal product.
- Wash hands after use.
- This veterinary medicinal product may cause skin and eye irritation. Therefore, the user should avoid contact of the veterinary medicinal product with the skin and the eyes. In case of contact, rinse immediately with plenty of water.
- In the case of accidental ingestion or eye irritation after contact seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy and lactation: Can be used during pregnancy or lactation.
Interactions: The effects of GABA agonists are increased by ivermectin.
Withdrawal periods: Meat and offal: 34 days. Not authorised for use in animals producing milk for human consumption.
Adverse events and overdose
Adverse events in horses: None known. 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 its local representative or the national competent authority via the national reporting system.
Overdose: Mild transitory signs (slowed pupillary light response and depression) have been seen at a higher dose of 1.8 mg/kg (9 times the recommended dose level). Other signs seen at higher doses include mydriasis, ataxia, tremors, stupor, coma and death. The less severe signs have been transitory. Although no antidote has been identified, symptomatic therapy may be beneficial.
Storage and disposal
- Do not store above 25 °C.
- The veterinary medicinal product should not enter water courses as ivermectin is extremely dangerous to fish and other aquatic organisms.
- Medicines should not be disposed of via wastewater or household waste. 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.
