Downland Fluke and Worm Oral Suspension

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

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

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Pharmaceutical form

Oral Suspension

A bright yellow, viscous suspension

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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.

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Target species

Cattle, sheep

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Indications

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.

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Dosage

Thoroughly shake the container well before use to ensure that the two active substances are homogeneously resuspended and therefore the animals receive the correct dose.

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.

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked. Animals should be dosed according to their individual weight, and not dosed as per the heaviest animal in the group, otherwise signs of overdose may occur (see section 4.10).

Do not mix with other products.

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Contraindications

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

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Adverse reactions

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, animals may also display signs of ataxia, incoordination, recumbency and depression. Photosensitisation associated with inflammation of the skin (particularly non pigmented skin e.g. muzzle, udder) has been observed to occur very rarely and which may be painful and lead to skin sloughing in severe cases.

Additionally, rarely, sheep may show an allergic reaction such as submandibular oedema, ear flap oedema and swelling of the head. If such a reaction occurs, appropriate treatment should be administered without delay. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening.

The frequency of adverse reactions is defined using the following convention:

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

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Warnings

i Special precautions for use in animals

Care should be taken to estimate accurately the liveweight of animals to be treated. Animals should not be dosed as per the heaviest animal in the group. 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 and stock management to achieve adequate parasite control and 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.

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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.

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Interactions

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

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Overdose

Do not overdose. If recommended dosages are exceeded, animals may exhibit signs of overdosage and toxicity. The effects of levamisole overdosage include impaired motor function i.e. muscle tremors, head shaking, increased salivation, facial swelling, oedema, scouring and in most severe cases, death. 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.

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Special warnings

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.

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Withdrawal period

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.

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Incompatibilities

None known

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Immediate packaging

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.

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Storage

Do not store above 25ºC. Protect from light.

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Shelf life

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

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Disposal of unused product

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

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Additional information

Vm 02000/4169

9 DATE OF FIRST AUTHORISATION

22 October 1996

10 DATE OF REVISION OF THE TEXT

May 2023

Approved: 04 May 2023

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Registration holder

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

United Kingdom

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