Contraindications
Do not use in foals under 2 weeks of age.
Do not use in horses known to be hypersensitive to active ingredients or to any other ingredients.
Special warnings for each target species
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.
Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Special precautions for use
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 veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Other precautions
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.
Adverse reactions (frequency and seriousness)
Horses:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Colic 1,3, Loose Stool 2 , Diarrhoea 3 Anorexia 3 Allergic reaction (such as hypersalivation, lingual oedema, urticaria, tachycardia, congested mucous membrane, Allergic oedema) |
Undetermined frequency (cannot be estimated from the available data) | Swelling 4 Itching 4 |
1 Mild transient in case of very high levels of infestation, caused by destruction of the parasites
2 In case of very high levels of infestation, caused by destruction of the parasites
3 In particular when there is heavy worm burden.
4 For horses carrying heavy infection of Onchocerca microfilariae. It is assumed that these reactions are the result of the destruction of large numbers of microfilariae.
A veterinarian should be consulted if these signs persist.
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 and lactation:
Can be used during pregnancy and lactation.
Fertility:
The veterinary medicinal product can be used safely in stallions
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
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 to fish and other aquatic organisms.
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.