SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Chanaverm 7.5% Oral Solution.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

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.

3. PHARMACEUTICAL FORM

Oral solution.

A yellow coloured clear solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle and Sheep

4.2 Indications for use, specifying the target species

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., Bunostomum spp., Oesophagostomum spp., Chabertia spp.

Lungworms: Dictyocaulus spp.

Not effective against Type II winter scour.

4.3 Contraindications

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

4.4 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.

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.

Resistance to levamisole has been reported in Teladorsagia, Cooperia and Trichostrongylus species in sheep. There are reports of resistance in Haemonchus in sheep in various parts of the world other than the EU. Resistance to levamisole has been reported in Teladorsagia species in cattle in 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.

4.5 Special precautions for use

i. Special precautions for use in animals

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

For oral use only

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

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.

4.6 Adverse reactions (frequency and seriousness)

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

4.7 Use during pregnancy, lactation or lay

Can be safely used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

See 4.3 (2).

4.9 Amounts to be administered and administration route

The product should only be administered as an oral drench. The 500 ml Armadose presentation is for use only with the Armadose worming system. The 1L, 2.5L and 5L presentations are for use with conventional dosing gun systems. Dosing should be carried out accurately, at a dose rate of 7.5 mg Levamisole HCl per kg bodyweight.

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

Dosage guide:

Cattle: 1 ml/10 kg bodyweight		Sheep: 0.5 ml/5 kg bodyweight
Bodyweight	Dose (ml)	Bodyweight	Dose (ml)
50 kg (approx. 1 cwt)	5	10 kg (approx. 22 lb)	1
100 kg (approx. 2 cwt)	10	20 kg (approx. 44 lb)	2
150 kg (approx. 3 cwt)	15	30 kg (approx. 66 lb)	3
200 kg (approx. 4 cwt)	20	40 kg (approx. 88 lb)	4
250 kg (approx. 5 cwt)	25	50 kg (approx. 110 lb)	5
300 kg (approx. 6 cwt)	30	60 kg (approx. 132 lb)	6
Cattle over 300 kg should be given a further 1 ml for each additional 10 kg bodyweight		Sheep over 60 kg should be given a further 0.5 ml for each additional 5 kg bodyweight

Veterinary advice should be sought:

Do not mix with other products.

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

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.

4.11 Withdrawal period(s)

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

5. PHARMACOLOGICAL PROPERTIES

Levamisole Hydrochloride is a highly effective anthelmintic agent.

ATCvet code: QP52AE01

Levamisole Hydrochloride is a highly effective anthelmintic agent. Levamisole Hydrochloride is the laevoisomer of tetramisole hydrochloride. It is a broad spectrum anthelmintic with activity against a wide range of gastro-intestinal helminths and lungworms in cattle and sheep.

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Metabisulphite

Tartrazine E 102

Disodium Phosphate Dihydrate

Citric Acid Monohydrate

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

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

6.4. Special precautions for storage

Do not store above 25˚C. Protect from light.

6.5 Nature and composition of immediate packaging

1L, 2.5L and 5L white high density polythene containers, with polypropylene closures covered with aluminium foil seals and 500 ml clear low density polyethylene flexipack with bromobutyl rubber bungs and aluminium overseals.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

Chanelle Animal Health Ltd.,

7 Rodney Street,

Liverpool L1 9HZ,

UK.

8. MARKETING AUTHORISATION NUMBER(S)

Vm11990/4002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 27 January 1993

Date of Renewal of Authorisation: 27 January 2008

10. DATE OF REVISION OF THE TEXT

April 2011