Target species
Cattle, Sheep
Indications for use, specifying the target species
A broad spectrum anthelmintic for use in the treatment and control of nematode infections. The veterinary medicinal product should be used in cases of parasitic gastro-enteritis and lungworm disease caused by mature and developing immature forms of those organisms sensitive to treatment with levamisole hydrochloride.
Lungworms (adult and larval stages):
Dictyocaulus spp.
Gastro-intestinal worms (adult and larval stages):
Trichostrongylus spp.
Cooperia spp.
Ostertagia spp. (except inhibited Ostertagia larvae in cattle)
Haemonchus spp.
Nematodirus spp.
Bunostomum spp.
Oesophagostomum spp.
Chabertia spp.
Contraindications
Animals must not be treated within a period of 14 days before or after treatment with organophosphorus compounds.
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, 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.
Special precautions for use
Special precautions for use in the target species:
Care should be taken to estimate accurately the liveweight of animals to be treated. After treatment animals should be moved to clean pasture in order to prevent re-infection.
Veterinary advice should be sought:
1On appropriate dosing programmes and stock management to achieve adequate parasite control, and to reduce the likelihood of anthelmintic resistance developing.
2If the product does not achieve the desired clinical effect since 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
Do not eat, drink or smoke when using this product. Care should be taken to avoid accidental self-injection: may cause irritation at site of injection. Wash splashes from eyes and skin immediately. If irritation persist, seek medical advice and show the package leaflet or the label to the physician.. Remove any contaminated clothing immediately. Wash hands and exposed skin after handling this product and before meals. 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 seek medical advice immediately and show the package leaflet or
the label to the physician..
Adverse reactions (frequency and seriousness)
Target species: Cattle and sheep.
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site reaction1 |
1 Normally non-irritant and should resolve naturally in a short period of time.
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 package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The product can be safely administered to pregnant or lactating animals However care should be taken when treating heavily pregnant animals and animals under stress from adverse weather conditions, poor nutrition, penning, handling etc.
Interaction with other medicinal products and other forms of interaction
Levamisole activity is not affected by benzimidazole resistance.
Administration routes and dosage
The veterinary medicinal product should be administered by subcutaneous injection at a rate of 7.5 mg Levamisole per kg bodyweight.
Usual aseptic precautions should be observed. Cattle should be dosed at a rate of 1 ml of product per 10 kg bodyweight and sheep at a rate of 0.5 ml per 5 kg bodyweight. To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.
The veterinary medicinal product is to be administered using a draw off needle. Divide large doses between two or more injection sites. Do not mix with any other products before administration except if premixing is done by a veterinary surgeon or a pharmacist.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Levacide Injection is safe for use in cattle and sheep at the recommended dosages. However, if recommended doses are exceeded animals may exhibit signs of impaired motor functions such as muscle tremors and increased salivation, which are of a temporary nature.
Withdrawal period
Cattle
Meat and offal: 28 days
Sheep
Meat and offal: 15 days
Not authorised for use in cattle and sheep producing milk for human consumption.