Indications for use, specifying the target species
For the treatment of the following parasites of horses:
Roundworms in the stomach and intestines
adults and 4th larval (arterial) stages
adults and 4th larval (tissue) stages
Small strongyles, adults
adult and immature
adult and 3rd and 4th stage
Onchocerca spp (microfilariae)
adult and immature
oral and gastric larval stages
Ivermectin is not effective against encysted larval stages of the small strongyles.
Do not use in horses known to be hypersensitive to the active ingredient or to any other ingredients.
Do not use in dogs or cats as severe adverse reactions may occur.
See also section, "Withdrawal Period(s)"
Special Warnings for Each Target Species
The veterinary medicinal product has been formulated specifically for use in horses only. Dogs and cats may be adversely affected by the concentration of ivermectin in the veterinary medicinal product if they are allowed to ingest spilled paste or have access to used syringes.
As with all anthelmintics, a veterinary surgeon should establish appropriate dosing programmes and stock management to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance developing.
Special Precautions for Use
Special precautions for use in animals:
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).
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Do not smoke or eat while handling the veterinary medicinal product.
Wash hands after use.
Avoid eye contact.
Adverse reactions (Frequency and Seriousness)
Some horses carrying heavy infection of Onchocerca microfilariae have experienced oedema and pruritus following dosing, 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.
Frequent and repeated use may lead to the development of resistance.
Use during pregnancy, lactation or lay
The veterinary medicinal product can be administered at any stage of pregnancy.
Ivermectin passes readily into milk. When administering to lactating females, residues of ivermectin could be present in the maternal milk. No studies have been reported on the effect of ingestion of milk on the development of newborn foals.
Do not use in mares producing milk for human consumption.
Interactions with other medicinal products and other forms of interaction
Amounts to be Administered and Administration Route
The veterinary medicinal product is administered orally at a single dose rate of 200 μg/kg of bodyweight. One syringe division of paste should be administered per 100 kg bodyweight [based on the recommended dosage of 200 μg/kg (0.2 mg/kg)]. Each syringe delivers 140 mg ivermectin, sufficient to treat 700 kg of bodyweight. Horses weight should be accurately determined for the correct use of the paste. The animal’s mouth should be free from food to ensure swallowing. The tip of the syringe barrel should be inserted at the interdental space (the gap between the front and back teeth). Immediately elevate the horse’s head for a few seconds to ensure swallowing.
Do not use the same syringe to treat more than one animal unless horses are running together or in direct contact with each other on the same premises.
For best results all horses in a yard or grazing together should be included in a regular parasite control programme, with particular attention being paid to mares, foals and yearlings, and treated at the same time. Foals should be treated initially at 6-8 weeks of age and routine treatment repeated as appropriate.
Retreatment should be done according to the epidemiological situation, but not less than 30 days interval.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
Edible tissues: 34 days
Not permitted in mares producing milk for human consumption.