SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Downland Fluke and Worm Oral Suspension

2. Qualitative and quantitative composition

Active Substances:

% w/v

Levamisole Hydrochloride 3.0

Oxyclozanide 6.0

Excipients:

Sodium methylhydroxybenzoate (preservative) 0.18

Sodium Metabisulphite (antioxidant) 0.15

Disodium Edetate (antioxidant) 0.05

Tartrazine (E102) (colour) 0.011

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Oral Suspension

A bright 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 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.

To date, no resistance to oxyclosanide has been reported. The use of this product should be based on local (regional, farm) epidemiological information about susceptibility of trematodes 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 estimate accurately the liveweight of animals to be treated. It is important that the container is shaken before use. After treatment, animals should be moved to clean pasture in order to prevent re-infection. Veterinary advice should be sought on appropriate dosing programmes to reduce the likelihood of anthelmintic resistance developing. Veterinary advice should be sought if the product does not achieve the desired clinical effect since other diseases, nutritional disturbances or anthelmintic resistance may 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. 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)

At normal oxyclozanide dose levels, cattle may show slight softening of the faeces with the occasional animal showing increased frequency of defecation and transient inappetence. Rarely, sheep may show an anaphylactic reaction with swelling of the head.

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

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

4.9 Amounts to be administered and administration route

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

Shake the container well before use.

Dosing must be carried out using a suitable gun system, at a rate of 7.5 mg/kg bodyweight levamisole hydrochloride and 15 mg/kg bodyweight oxyclozanide achieved by administering 2.5 ml per 10 kg bodyweight in cattle and 0.5 ml per 2 kg bodyweight in sheep.

Do not mix with other products.

If recommended dosages are exceeded animals may exhibit signs of overdosage. 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. Oxyclozanide may produce inappetence and loss of bodyweight, dullness and some loosening of faeces in sheep, and possible 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

This product must not be used in cattle and sheep producing milk for human consumption.

5. pharmacological properties

Pharmacotherapeutic group: Anthelmintic

ATC Vet Code: QP 52 AE 51

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 gastrointestinal 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

Antifoam M30

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.

White, opaque low density polyethylene flexipacks of 1.0, 2.5 and 4.0 litres, with white wadded polypropylene caps (screw-fit).

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materias 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 02000/4169

9. DATE OF FIRST AUTHORISATION

22 October 1996

10. DATE OF REVISION OF THE TEXT

August 2010