PHARMACEUTICAL FORM: oral solution
TARGET SPECIES: Cattle, Sheep, Pigs, Chickens (Broilers), Turkeys, Ducks and Pigeons not intended for human consumption.
INDICATIONS:
In cattle, sheep, pigs: it is indicated in the treatment and control of parasitic infestations caused by:
– pulmonary parasites: Dictyocaulus spp, Metastrongylus spp and Protostrongylus spp.
– gastrointestinal nematodes: Haemonchus spp., Cooperia spp, Bunostromum spp., Nematodirus spp., Oesophagostomum spp., Strongyloides spp. and Ascaris spp.
In chickens (broilers), turkeys, ducks and pigeons not intended for human consumption: it is indicated in the treatment of infestations caused by the larval and adult stages of the following parasites: Ascaridia spp., Heterakis gallinarum, Capillaria spp. and Syngamus trachea.
COMPOSITION:
1 ml of product contains:
Active substance:
Levamisole hydrochloride …………………………………100 mg
Excipients:
Methyl parahydroxybenzoate ……………………………2 mg
Propyl parahydroxybenzoate……………………….…..0.2 mg
Propylene glycol, disodium edetate, monosodium phosphate dihydrate, distilled water.
CONTRAINDICATIONS:
Do not use in animals with severe liver or kidney disease.
Do not use in animals with pre-existing blood diseases.
Do not use in dehydrated, stressed or very weak animals.
Do not administer in case of hypersensitivity to the active substance or any of the excipients.
ADVERSE REACTIONS:
Side effects of levamisole are rare if it is administered in the recommended doses.
Foaming at the mouth or salivation may occur. This reaction is occasionally observed and will disappear after a few hours of administration.
Animals with serious lung disease caused by heavy parasite infestations may react by coughing and vomiting. These symptoms are caused by the migration of parasites from the lungs and last for several hours.
If you notice any serious reactions or other effects not mentioned in this leaflet or you think that the medicine has not had an effect, please inform your veterinarian.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION:
To be administered orally, by dilution in drinking water, with a single administration.
Cattle, sheep, : 7.5 mg active substance/ kg body weight
Individual administration: 0.75 ml product/ 10 kg body weight
Swine: 10 mg active substance/ kg body weight
Mass administration: 1L product/ 1000 L drinking water
Chickens (broilers), turkeys, ducks: 20-30 mg active substance/ kg body weight
– 10-15 ml/ 10 liters of drinking water
– 1-1.5 liters/ 1000 liters of drinking water
Pigeons not intended for human consumption: 1.6 ml/ 2 liters of drinking water (quantity for 20 pigeons)
In cases of massive infestations, the treatment is repeated after 7-10 days.
The intake of medicated water depends on the clinical conditions of the animals.
During the treatment period, only medicated drinking water should be administered to animals.
To ensure correct dosing, the body weight of the animals should be determined as accurately as possible.
If the animals do not show an improvement in their health, consult a veterinarian for re-evaluation of the diagnosis.
RECOMMENDATIONS ON CORRECT ADMINISTRATION:
Do not use the product if you notice visible signs of damage to the primary packaging.
WITHDRAWAL PERIOD:
Meat and offal:
Cattle, sheep: 11 days
Pigs: 10 days
Chickens (broilers), turkeys, ducks: 4 days
Not authorised for use in lactating animals producing milk for human consumption.
Not authorised for use in laying birds producing eggs for human consumption.
Not authorised for use in pigeons whose meat is intended for human consumption.
SPECIAL STORAGE PRECAUTIONS:
Keep out of the sight and reach of children.
Store below 250C.
Store in the original packaging.
Do not freeze.
Protect from light.
Do not use after the expiry date stated on the bottle.
Shelf life after first opening the primary packaging: 3 months
Shelf life after dilution according to indications: 24 hours
SPECIAL WARNINGS:
Special warnings for each target species:
The following practices should be avoided, as they increase the risk of resistance development and ultimately lead to ineffective treatment:
– frequent and repeated use of antiparasitics from the same class over a long period of time
– underdosing, which may result from underestimation of the body weight of the animals
Clinical cases suspected of resistance to anthelmintics should be investigated by appropriate methods (ovocoproscopy, etc.). If the test results clearly indicate the establishment of resistance to a particular anthelmintic, another anthelmintic from a different pharmacological class and with a different mode of action should be used.
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