Introduction

Company name: Janssen Animal Health

A division of Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

Telephone: 01494 567555

Fax: 01494 567556

Email: ahealth@jacgb.jnj.com

Presentation

Oral Solution containing 75 mg/ml levamisole hydrochloride.

Uses

A broad spectrum anthelmintic for the treatment and control of gastro-intestinal and pulmonary nematode infections in cattle and sheep, effective against mature and developing immature stages of the following levamisole-susceptible major nematode worm species:

Gastro-intestinal Worms

Trichostrongylus spp.

Cooperia spp.

Ostertagia spp.

(except inhibited Ostertagia larvae in cattle)

Haemonchus spp.

Nematodirus spp.Bunostomum spp.

Oesophagostomum spp.

Chabertia spp.

Lungworms

Dictyocaulus spp.

Not effective against Type II winter scour.

Dosage and administration

The product should only be administered as an oral drench with conventional dosing gun systems. Dosing should be carried out accurately, at a dose rate of 7.5 mg levamisole HCl/kg.

Dose

Cattle: 1 ml per 10 kg bodyweight

Sheep: 0.5 ml per 5 kg bodyweight

Contra-indications, warnings, etc

Not for use in animals producing milk for human consumption. Animals should not be treated simultaneously or within 14 days before or after use with organophosphorous compounds or diethylcarbamazine citrate.

Special warnings for each target species

The product may be given to young, pregnant and lactating animals, but due regard must always be paid to the animals physical condition and the presence of inter-current disease. When a dosing gun is used to administer the product, care should be taken to avoid the occurrence of dosing gun pharyngitis.

Special precautions for use

Care should be taken to accurately estimate the bodyweight of animals to be treated before calculating the dose.

Special precautions for use in animals

For oral use only.

Special precautions to be taken by the person administering the product

Levamisole can cause idiosyncratic reactions as well as serious blood disorders in a very small number of people. If symptoms such as dizziness, nausea or 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. Wash hands and exposed skin before meals and after work. Remove immediately any contaminated clothing. Wash splashes from eyes and skin immediately. If irritation persists, consult your doctor. When using, do not eat, drink or smoke.

Adverse reactions

Occasionally at the recommended dose cattle may show signs of lip-licking and slight muscle tremor.

Use during pregnancy, lactation

Can be safely used during pregnancy and lactation.

Drug interaction

Animals should not be treated simultaneously or within 14 days before or after use with organophosphorous compounds or diethylcarbamazine citrate.

Overdose

At normal therapeutic dosages side effects are rarely seen. Overdose may occasionally result in the appearance of cholinergic-type symptoms such as salivation, muscular tremors and head shaking. They are more likely to be observed in cattle than in sheep.

Withdrawal period

Animals must not be slaughtered for human consumption during treatment. Cattle and sheep may be slaughtered for human consumption only after 20 days from the last treatment. Not for use in animals producing milk for human consumption.

Pharmaceutical precautions

Storage precautions

Do not store above 25 °C.

Protect from light.

For animal treatment only.

Keep out of reach of children.

Disposal

Any unused veterinary medicinal product or waste materials derived from such a veterinary medicinal product should be disposed of in accordance with local requirements.

Legal category

POM-VPS

Packaging Quantities

2.5 L and 5 L

Further information

Levamisole hydrochloride is the laevoisomer of tetramisole hydrochloride. Levamisole is a ganglion stimulant of the nervous system of nematodes causing neuromuscular paralysis of the parasites. Because it acts on the nervous system it is not ovicidal.

Marketing authorisation number

Vm 00242/4062.

Significant Changes