LEVAVERMIN 50 mg/ml

COMPOSITION

Active substance:

Levamisole (as levamisole hydrochloride )   50 mg/ml

Excipients:

Methylparaben                               0.5 mg/ml

Sodium Metabisulphite              0.5 mg/ml

CONTRAINDICATIONS

Do not use in case of known hypersensitivity to the active substances or to any of the excipients.

Do not use in case of levamisole resistance is suspected.

ADVERSE REACTIONS

In rare cases the following adverse reactions may appear: salivation, diarrhea, agitation and tremors.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Oral administration

Dose:

Cattle and sheep:
7,5 mg levamisole /kg body weight,  single administration, without exceeding the total dose of 3,75 g levamisole in cattle and  0,375 g levamisole in sheep (0,15 ml product per kg body weight, not exceeding the dose of 75 ml for cattle and 7,5 ml for sheep.)

Pigs: 7,5 mg levamisole /kg body weight single administration, without exceeding the total dose of 0.75 g levamisole per animal (0.15 ml product per kg body weight, not exceeding a dose of 15 ml).

 Chickens (broilers): 20 mg levamisole /kg body weight, about 4 ml per liter of drinking water.

ADVICE ON CORRECT ADMINISTRATION

To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

WITHDRAWAL PERIOD

Meat and offal: 3 days.

Not authorized for use in animals producing milk for human consumption.

Do not use in birds producing eggs for human consumption.

SPECIAL STORAGE PRECAUTIONS

Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Protect from direct sunlight.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.            

SHELF-LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 1 year.

Shelf life after first opening of the immediate packaging: 28 days.

Shelf life after reconstitution in drinking water: 24 hours.                

SPECIAL WARNINGS

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 bodyweight, 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 in animals

None.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Avoid direct contact with the skin. Wash hands after use.
Wear suitable protective clothing, including waterproof rubber gloves, when handling the product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

People with known hypersensitivity to levamisole should avoid contact with the medicinal product.

Use during pregnancy, lactation or lay

Studies in laboratory animals have not revealed any evidence of teratogenic effects.

Studies in cattle, sheep and pigs have not shown embryotoxic or teratogenic potential.

The product can be use during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

Co-administration with organophosphorus insecticides may occasionally produce toxic reactions.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose, the signs observed are those resulting from the stimulation of the parasympathetic nervous system: salivation, vomiting, diarrhea, rapid breathing and ataxia, tremor, convulsions.

Atropine or glycopyrolate are used as an antidote.

Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary  how to dispose of medicines no longer required. These measures should help to protect the environment.

PRESENTATION/PACKAGE

White HDPE vials of 50 ml, 100 ml, 250 ml, 500 ml and HDPE canisters of 1 L, 5 L, 10 L, 20 L.