Contraindications
•Do not use in animals with known hypersensitivity to the active ingredient or any of the excipients.
Special warnings
Care should be taken to avoid the following practices because they increase the risk of 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 or misadministration of the product.
Resistance to ivermectin (an avermectin) has been reported in Teladorsagia in sheep and goats within the EU and it is common in Haemonchus in sheep outside the EU. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematode and recommendations on how to limit further selection for resistance to anthelmintics.
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.
The veterinary medicinal product has a cross-resistance with other avermectins and with milbemycins.
Special precautions for use
Special precautions for safe use in the target species:
The timing of treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing programme should be established by the veterinary surgeon.
Veterinary advice should be sought on appropriate dosing programmes and stock management to achieve adequate parasite control, and to reduce the likelihood of anthelmintic resistance developing. Veterinary advice should also be sought if the product does not achieve the desired clinical effect, as other diseases, nutritional disturbances or anthelmintic resistance might be involved.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
Do not eat, drink or smoke while handling the veterinary medicinal product.
Avoid contact with skin and eyes.
Personal protective equipment consisting of impervious gloves should be worn when handling the veterinary medicinal product.
As absorption through skin can occur, in the event of accidental skin contact, wash the affected area immediately with soap and water.
If accidental eye exposure occurs, flush the eyes immediately with water.
Special precautions for the protection of the environment:
The veterinary medicinal product is extremely dangerous to fish and aquatic life.
Do not contaminate surface waters or ditches with product or used container.
Other precautions:
Avermectins may not be well tolerated in non-target species. Cases of intolerance resulting in fatalities have been reported in dogs, especially Collies, Old English Sheep Dogs and related breeds or crosses, and also in turtles/tortoises.
Adverse reactions
Sheep:
Frequency underdetermined | Cough1 |
1 immediately after treatment and this passing response is of no consequence.
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 the national competent authority via the national reporting system. See the immediate packaging for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation provided that the milk is not used for human consumption.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
At doses up to 4 mg ivermectin per kg administered by stomach tube (20x the recommended dose level) undesirable toxic reactions occurred. Acute symptoms (ataxia, staggering gait, incoordination, depression) were observed at the dose rate of 8 mg/kg (40x the recommended dose level) during a study carried out on 4 animals. Twenty-four hours later, the animals showed only mild incoordination and depression.
Three days post dose all the animals were nearly normal. It is possible that the signs of toxaemia were due to the propylene glycol.
No antidote has been identified. Symptomatic treatment may be beneficial.
Withdrawal periods
Meat and offal: 10 days.
Milk: Not authorised for use in lactating sheep producing milk for human consumption.
Sheep must not be treated within 60 days prior to the commencement of lactation, if milk is to be used for human consumption.