Target species
Horses
Indications for use, specifying the target species
For the treatment of the following parasites of horses:
| Roundworms in the stomach and intestines | 
| Large strongyles | Strongylus vulgaris | adults and 4th larval (arterial) stages | 
|  | Strongylus edentatus | adults and 4th larval (tissue) stages | 
|  | Strongylus equinus | adults | 
| Small strongyles, adults | Cyathostomum catinatum |  | 
|  | Cyathostomum pateratum |  | 
|  | Cylicocyclus ashworthi |  | 
|  | Cylicocyclus elongatus |  | 
|  | Cylicocyclus insigne |  | 
|  | Cylicocyclus leptostomum |  | 
|  | Cylicocyclus nassatus |  | 
|  | Cylicoyclus radiatus |  | 
|  | Cylicostephanus asymetricus |  | 
|  | Cylicostephanus bidentatus |  | 
|  | Cylicostephanus calicatus |  | 
|  | Cylicostephanus goldi |  | 
|  | Cylicostephanus longibursatus |  | 
|  | Cylicostephanus minutus |  | 
|  | Cylicodontophorus bicornatus |  | 
|  | Gyalocephalus capitatus |  | 
| Hairworms | Trichostrongylus axei | adult | 
| Pinworms | Oxyuris equi | adult and immature | 
| Ascarids | Parascaris equorum | adult and 3rd and 4th stage | 
| Intestinal threadworms | Strongyloides westeri | adult | 
| Neck threadworms | Onchocerca spp (microfilariae) |  | 
| Lungworms | Dictyocaulus arnfieldi | adult and immature | 
| Stomach bots | Gasterophilus spp | oral and gastric larval stages | 
|  | 
Ivermectin is not effective against encysted larval stages of the small strongyles.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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
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.
Special precautions for the protection of the environment:
Extremely dangerous to fish and aquatic life. See section: Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Adverse reactions (Frequency and Seriousness)
Very rarely 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. 
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, lactation or lay
Pregnancy: 
Can be used during pregnancy.
Lactation:
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.
Fertility:
Horses of all ages, including young foals, pregnant mares and breeding stallions have been treated with no adverse effects on their health and fertility.
Interactions with other medicinal products and other forms of interaction
None known.
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.
Withdrawal Period(s)
Meat and offal: 34 days
Not authorised for use in animals producing milk for human consumption.