Target species
Sheep
Indications for use, specifying the target species
Treatment and control of gastrointestinal nematodes, lungworms and nasal bots of sheep.
Gastrointestinal worms (adult and immature):
Haemonchus contortus, Ostertagia circumcincta, Trichostrongylus spp, Cooperia spp, Nematodirus spp including N. battus, Strongyloides papillosus, Oesophagostomum spp, and adult Chabertia ovina.
Inhibited larval stages and benzimidazole resistant strains of H. contortus and Ostertagia circumcincta are also controlled.
Lungworms (adult and immature):
Dictyocaulus filaria
Nasal bot (all larval stages):
Oestrus ovis
Contraindications
The product has been formulated specifically for use in sheep. It should not be used in other species, as severe adverse reactions, including fatalities in dogs, may occur.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
The product is not for intravenous or intramuscular use.
Do not use in sheep producing milk for human consumption.
Special warnings for each target species
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, 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 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 nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid contact with skin and eyes.
In case of accidental spillage onto the skin or eyes, wash the affected area with clean running water immediately. Seek medical attention if irritation persists.
Do not smoke, drink or eat while handling the product.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Some animals may cough slightly immediately after treatment. This is a temporary occurrence and is of no clinical consequence.
Use during pregnancy, lactation or lay
The product can be administered to ewes at any stage of pregnancy or lactation provided that the milk is not used for human consumption.
Interaction with other medicinal products and other forms of interaction
None known.
Amount(s) to be administered and administration route
Ivermectin should be administered at a dosage rate of 200 μg per kg bodyweight (2.5 ml per 10 kg bodyweight). It should be administered orally. It is recommended that a suitably calibrated dosing gun is used to allow accurate dosing especially in young animals.
To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.
Do not mix with other products.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The product has demonstrated a wide safety margin at the recommended dose rate.
No antidote has been identified however symptomatic treatment may be beneficial.
Withdrawal period(s)
Meat and offal: 14 days
Do not use in sheep producing milk for human consumption.