Contraindications
Do not use in foals under 2 weeks of age.
Do not use in mares from which milk is taken for human consumption.
Do not use in horses known to be hypersensitive to active ingredients or to any other ingredients
Special warnings for each target species
The product can be used safely in stallions.
Care should be taken to avoid the following practices because they increase the risk of the 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, 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 (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 (an avermectin) has been reported in Parascaris equorum in horses in a number of countries including the EU. 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
i. Special precautions for use in animals
Avermectins may not be well tolerated in all non target species. Cases of intolerance are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles and tortoises.
Dogs and cats should not be allowed to ingest spilled paste or access to used syringes due to the potential for adverse effects related to ivermectin toxicity.
Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use (to be sure that eye contamination can not occur). Avoid contact with the eyes. In the case of accidental contact, rinse with abundant quantities of water. In case of eye irritation, seek medical attention. Do not eat, drink or smoke while handling this product. In the event of accidental ingestion, seek medical advice and show the doctor the leaflet so that he knows what you have taken.
Adverse reactions (frequency and seriousness)
Horses carrying heavy infection of Onchocerca microfilariae have experienced such reactions as swelling and itching after treatment. It is assumed that these reactions are the result of the destruction of large numbers of microfilariae.
In case of very high levels of infestation, destruction of the parasites may cause a mild transient colic and loose faeces in the treated horse.
Colic, diarrhea and anorexia have been reported in vary rare occasions post treatment, in particular when there is heavy worm burden.
In very rare occasions, allergic reactions such as hypersalivation, lingual oedema and urticaria, tachycardia, congested mucus membranes, and subcutaneous oedema have been reported following treatment with the product.
A veterinarian should be consulted if these signs persist.
Use during pregnancy, lactation or lay
The product can be used safely in mares during the whole pregnancy period and lactation period. 4.8 Interaction with other medicinal products and other forms of interaction None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
A tolerance study performed in foals from 2 weeks of age with doses up to 5 times the recommended dosage showed no adverse reactions.
Safety studies conducted with the veterinary medicinal product administered to mares at 3 times the recommended dosage at 14 day intervals during the whole gestation and lactation did not show any abortions, any adverse effects on the gestation, parturition and on the mares general health, nor any abnormalities on the foals.
Safety studies conducted with the veterinary medicinal product administered to stallions at 3 times the recommended dosage did not show any adverse effects in particular on the reproductive performances.
Withdrawal period
In Horses: Meat and Offal: 35 days
Not permitted for use in horses 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
Any unused product or waste material should be disposed of in accordance with national requirements.
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container.