SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Levafas Oral Suspension Fluke and Worm Drench

2. Qualitative and quantitative composition

Active Substance:

1.5% w/v Levamisole Hydrochloride

3.0% w/v Oxyclozanide

Excipients:

0.18% w/v Sodium Methylhydroxybenzoate as an antimicrobial preservative

0.15% w/v Sodium Metabisulphite as an antioxidant

0.05% w/v Disodium Edetate Dihydrate as an antioxidant

0.011% w/v Tartrazine (E102) as a colour

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Oral suspension

A yellow viscous suspension

4. Clinical Particulars

4.1 Target species

Cattle

Sheep

4.2 Indications for use, specifying the target species

For the treatment and control of both gastrointestinal and pulmonary nematode infections, and adult liver fluke infections. The product also removes most mature Fasciola spp (flukes) present in the bile ducts of the liver.

4.3 Contraindications

Animals must not be treated within a period of 14 days before or after treatment with organophosphorus compounds.

4.4 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 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 in a number of countries, including the EU. There are reports of resistance in Haemonchus in sheep outside the EU. Resistance to levamisole has been reported in Teladorsagia species 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.

In cases of lungworm infections, coughing may persist for a considerable time following successful treatment with Levafas Fluke and Worm Drench. This is due to tissue damage caused by the parasites.

4.5 Special precautions for use

i. Special precautions for use in animals

Shake the container before use. Care should be taken to estimate accurately the liveweight of animals to be treated. After treatment animals should be moved to clean pasture in order to prevent re-infection. Care must be taken when dosing animals to avoid damage with the dosing gun, which may result in pharyngitis.

Veterinary advice should be sought:

a) On appropriate dosing programmes and stock management to achieve adequate parasite control, and to reduce the likelihood of anthelmintic resistance developing.

b) If the product does not achieve the desired clinical effect since other diseases, nutritional disturbances or anthelmintic resistance might be involved.

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

Do not eat, drink or smoke when using this product. Wash splashes from eyes and skin immediately. If irritation persists seek medical advice. Remove any contaminated clothing immediately. Wash hands and exposed skin after handling this product, and before meals.

Levamisole can cause idiosyncratic reactions and serious blood disorders in a very small number of people. If symptoms such as dizziness, nausea, 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.

4.6 Adverse reactions (frequency and seriousness)

None

4.7 Use during pregnancy, lactation or lay

The product can be safely administered to pregnant or lactating animals. However care should be taken when treating heavily pregnant animals, and animals under stress from adverse weather conditions, poor nutrition, penning, handling etc.

4.8 Interaction with other medicinal products and other forms of interaction

Levamisole activity is not affected by benzimidazole resistance.

4.9 Amounts to be administered and administration route

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

Administer as an oral drench using a suitable dosing gun system, at a rate of 7.5 mg/kg bodyweight levamisole hydrochloride and 15 mg/kg bodyweight oxyclozanide achieved by administering 50 ml per 100 kg bodyweight in cattle and 5 ml per 10 kg bodyweight in sheep.

Do not mix with other products.

The effects of levamisole overdosage include impaired motor function i.e. muscle tremors, head shaking and increased salivation. These effects are transient and more likely to be found in cattle than in sheep. At normal oxyclozanide dose levels, animals may show slight softening of the faeces with the occasional animal showing increased frequency of defecation and transient inappetance. Oxyclozanide overdosage may produce inappetance and loss of bodyweight, dullness and some loosening of faeces in sheep, and possibly diarrhoea. The effects are occasionally enhanced in animals with severe liver damage and/or dehydration at the time of dosing.

Cattle (meat & offal): 5 days

Sheep (meat & offal): 5 days

Not to be used in animals producing milk for human consumption.

5. pharmacological properties

Pharmacotherapeutic group: Anthelmintic

ATC Vet Code: QP52AE51

5.1 Pharmacodynamic properties

Levamisole is an imidazothiazole that acts by interfering with parasite nerve transmission causing muscular paralysis. It is effective against adult and immature gastro-intestinal roundworm and lungworm infections. Oxyclozanide is a salicylanilide which is mainly active against adult liver flukes. It is distributed to the liver, kidney and intestines and is excreted in the bile.

6. Pharmaceutical particulars

6.1 List of excipients

Sodium Methyl Hydroxybenzoate

Sodium Metabisulphite

Disodium Edetate Dihydrate

Tartrazine (E102)

Sodium Citrate Dihydrate

Citric Acid Anhydrous

Polysorbate 80

Xanthan Gum

Simeticone

Water, Purified

6.2 Incompatibilities

None known

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

Do not store above 25ºC.

Protect from light.

Shake the container before use.

White low density polyethylene flexipacks with white polypropylene screw fit caps with low density polyethylene plastic coated paper washer, containing 1, 2.5 and 5 litres. Also available in white high density polyethylene jerry cans with white polypropylene screw fit caps and low density polyethylene plastic coated paper washer, containing 10 litres.

Not all pack sizes may be marketed.

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

Norbrook Laboratories Limited

Station Works

Newry

Co Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm 02000/4068

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 17 September 1985

10. DATE OF REVISION OF THE TEXT

August 2010