Contraindications
Do not use in dogs or cats as severe adverse reactions may occur.
Do not use in cases of known hypersensitivity to the active substance.
See also “Withdrawal periods”.
Special warnings for each target species
Strategies that should be avoided because they might lead to an increased risk of development of resistance to anthelmintic drugs include:
•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 (if any).
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests. 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 in horses. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use
Special precautions for use in animals
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
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.
As with all anthelmintics, a veterinary surgeon should establish appropriate dosing programs and stock management to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Do not eat, drink or smoke while handling the product. Avoid contact with skin and eyes. If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and, if necessary, get medical attention.
Wash hands after use.
Special precautions for the protection of the environment:
As ivermectin is extremely dangerous to fish and aquatic life treated animals should not have direct access to surface water and ditches during treatment.
Other precautions:
Avermectins 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).
Adverse reactions
Horses:
Undetermined Frequency (cannot be estimated from the available data) | Swelling* Itching* |
*For some horses carrying heavy infection of Onchocerca microfilariae and 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.
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. See the package leaflet for respective contact details.
Use during pregnancy and lactation
Can be used in pregnant mares. See “Withdrawal periods”.
Interaction with other medicinal products and other forms of interaction
The effects of GABA agonists are increased by ivermectin.
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.
Withdrawal period
Meat and offal : 30 days.
Do not use in mares producing milk for human consumption.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
The veterinary medicinal product should not enter water courses as ivermectin is extremely dangerous for fish and other aquatic organisms.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste material derived thereof of in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Do not contaminate surface water or ditches with the veterinary medicinal product or used containers.