Levacide Pour-on Solution 20% w/v for Cattle.
Indications for use, specifying the target species
Levamisole is a broad-spectrum anthelmintic indicated for use in cattle in the treatment and control of nematode infections such as parasitic gastro-enteritis and lungworm disease caused by the following mature and developing immature gastro-intestinal and pulmonary nematodes:
Lungworms - Dictyocaulus viviparus
Gastrointestinal worms - Trichostrongylus spp, Cooperia spp, Ostertagia ostertagi (except inhibited O. ostertagi larvae), Haemonchus spp, Nematodirus spp, Bunostomum spp, Oesophagostomum spp.
Special Warnings for each target species
In cases of lungworm infection coughing may persist for some time after treatment due to tissue damage.
For external use only.
Do not treat animals when wet, and where possible, for one hour post
treatment, prevent treated animals from being exposed to rain.
Special precautions for use
i) Special precautions for use in animals
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 levamisole has been reported in Teladorsagia, Cooperia and Trichostrongylus species in sheep in a number of countries, including the EU. There are reports of resistance in Haemonchus in sheep outside the EU. Resistance to levamisole has been reported in Teladorsagia species in cattle in developed countries such as New Zealand. 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.
Cattle must not be treated within a period of 14 days before or after treatment with organophosphorus compounds.
Do not exceed the stated dose.
The bodyweight of animals should be assessed as accurately as possible before calculating the dose.
As with other anthelmintics, veterinary advice should be sought:
(a) on appropriate dosing programmes and stock management to achieve adequate parasite control and to reduce the likelihood of anthelmintic resistance developing;
(b) if the product does not achieve the desired effect, as other diseases, nutritional disturbances or anthelmintic resistance may be present.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Highly flammable. Keep away from heat and sources of ignition.
Do not eat, drink or smoke when using this product. Wear rubber gloves, boots and waterproof bib-apron when applying this product. Avoid contact with skin and eyes. In case of accidental skin or eye contact, wash/irrigate splashes from skin and eyes immediately with clean water. If irritation persists seek medical advice. Remove any contaminated clothing immediately. Wash hands and exposed skin after handling this product and before meals. Use in a well ventilated area.
Levamisole can cause idiosyncratic reactions and serious blood disorders in a very small number of people. If symptoms such as dizziness, nausea, vomiting or abdominal discomfort are experienced when using this product or sore mouth/throat or fever occur shortly afterwards, then medical advice should be sought immediately.
Adverse reactions (frequency and seriousness)
The product is safe for use in cattle at the recommended dosage. In cases of overdosage (which only occurs at over five times the recommended dose rate), hyperaesthesia, tremor and occasionally diarrhoea may occur.
At the recommended dose rates animals should not show any adverse side effects. However, local skin irritation at the application site may be observed occasionally, characterised by subcutaneous oedema. Severe cases may show signs of epidermal flaking for which symptomatic treatment is recommended.
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