SUMMARY OF PRODUCT CHARACTERISTICS

Levamole 75 mg/ml Oral Solution

Levamisole Hydrochloride 7.5% w/v

Excipient(s):

Sodium Metabisulphite 0.1% w/v

Tartazine (E102) 0.00375% w/v

For a full list of excipients, see section 6.1.

Oral solution.

A yellow coloured clear solution.

Cattle and Sheep

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., Ostertagiaspp. (except inhibited Ostertagia larvae in cattle), Haemonchus spp., Nematodirus spp., Bunostomumspp., Oesophagostomum spp., Chabertia spp.

Lungworms: Dictyocaulusspp.

Not effective against Type II winter scour.

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

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.

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:

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, Cooperiaand Trichostrongylusspecies in sheep in a number of countries, including the EU. There are reports of resistance in Haemonchusin sheep in outside the EU.

Resistance to levamisole has been reported in Teladorsagiaspecies 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.

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

For oral use only

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.

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

Can be safely used during pregnancy and lactation.

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

The product should only be administered as an oral drench.

The 1L, 2.5L and 5L presentations are for use with conventional dosing gun systems.

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.

Do not mix with other products.

Dosing should be carried out, at a dose rate of 7.5 mg Levamisole HCl per kg bodyweight.

Dosage guide:

Cattle: 1 ml/10 kg bodyweight
Bodyweight	Dose (ml)
50 kg (approx. 1 cwt)	5 ml
100 kg (approx. 2 cwt)	10 ml
150 kg (approx. 3 cwt)	15 ml
200 kg (approx. 4 cwt)	20 ml
250 kg (approx. 5 cwt)	25 ml
300 kg (approx. 6 cwt)	30 ml
Cattle over 300 kg should be given a further 1 ml for each additional 10 kg bodyweight

Sheep: 0.5 ml/5 kg bodyweight
Bodyweight	Dose (ml)
10 kg (approx. 22 lb)	1 ml
20 kg (approx. 44 lb)	2 ml
30 kg (approx. 66 lb)	3 ml
40 kg (approx. 88 lb)	4 ml
50 kg (approx. 110 lb)	5 ml
60 kg (approx. 132 lb)	6 ml
Sheep over 60 kg should be given a further 0.5 ml for each additional 5 kg bodyweight

Veterinary advice should be sought:

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.

Cattle and sheep

Meat and offal: 20 days

Not for use in animals producing milk for human consumption

Pharmacotherapeutic group: Anthelmintic

ATCVet code:QP52AE01

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.

Sodium Metabisulphite

Tartrazine

Disodium Phosphate Dihydrate

Citric Acid Monohydrate

Purified Water

None known.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Do not store above 25˚C.

Protect from light.

1L, 2.5L and 5L high density polythene containers, with polypropylene closures covered with aluminium foil seals.

Not all pack sizes may be marketed.

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

Chanelle Pharmaceuticals Manufacturing Ltd

Loughrea

Co Galway

Ireland

Vm08749/4038

Date: 12 September 2007

Date: April 2014

02 April 2014