Introduction

Company name: Janssen Animal Health

A division of Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

Telephone: 01494 567555

Fax: 01494 567556

Email: ahealth@its.jnj.com

Presentation

Exodus is a ready-to-administer pale yellow to buff-coloured oral paste for horses and ponies. Each 28.5 g syringe contains 11.4 g pyrantel embonate as active ingredient and 0.0057g butylated hydroxytoluene.

Uses

Pyrantel embonate is a broad spectrum anthelmintic for treatment and control of adult infections of large and small strongyles, pinworms, roundworms and tapeworms.

Large strongyles: Stronglylus vulgaris, S. edentatus, S. equinus

Small strongyles:Trichonema spp. (Cyathostomes), Triodontophorus spp.

Pinworms: Oxyuris equi, Probstmayria vivipara

Large roundworms: Parascaris equorum

Tape worms: Anoplocephala perfoliata

Dosage and administration

The prescribed amount of Exodus is deposited on the tongue of the animal and the animal allowed to swallow. The complete content of one syringe contains 11.4g Pyrantel embonate (6 graduated doses of 1.9g) in 28.5g paste and is sufficient for the treatment of 600kg bodyweight. Each graduation of the syringe is sufficient for the treatment of 100kg 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.

Control and treatment of Strongyles, Oxyuris and Parascaris:

Exodus should be used at a dose rate of 19 mg Pyrantel embonate per kg bodyweight. The dosing programmes are as follows:

a) Foals (1-8 months of age): dose every 4 weeks.

b) Horses (over 8 months of age): dose every 6-8 weeks, but during the summer and autumn when at grass dose every 4-6 weeks. Always dose 3-4 days before turning out after in wintering.

c) Suckler mares: It has been shown that reduction of strongyle challenge to the suckling foal at pasture can be achieved by using clean pasture (re-seeded or not grazed the previous year by horses), dosing the mare 3-4 days before turning out and then at intervals of 2-4 weeks until the end of Autumn. Ideally mares with foals should go out to ‘clean’ pasture or, if this is not possible, delay turning them out until June.

Control and treatment of Anoplocephala (Tapeworm):

Exodus should be used at a dose rate of 38mg Pyrantel embonate per kg bodyweight (i.e. twice the dose used for stronglyes). The need for re-treatment may vary, but if considered necessary, should be carried out after an interval of 6 weeks.

Contra-indications, warnings, etc

Not to be used in horses and ponies intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.

Not for use in foals less than 4 weeks of age. Contraindicated in known sensitivity to Exodus and in severely debilitated animals.

Combined administration of pyrantel and levamisole or piperazine is not recommended.

The same syringe should only be used to dose two animals if they are both healthy and are either grazing together, or are on the same premises and in direct contact with each other.

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 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 pyrantel has been reported in cyathostomes in horses (also widespread in the USA and Canada). 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 resistence to anthelmintics.

Exodus is suitable for horses and ponies over one month of age, including suckling foals, pregnant mares and stallions. Impaction of the small intestines may occur in foals heavily infected with Parascaris equorum. Colic symptoms may be seen as soon as 30 minutes after treatment.

Use during pregnancy and lactation

Exodus is safe to give to pregnant and lactating mares provided the recommendations are followed.

Operator warnings

Direct contact with the skin should be avoided; wash hands and any other parts of the body which come into contact with the product after use. Avoid handling the product if you know you are hypersensitive to pyrantel.

For animal treatment only. Keep out of the reach and sight of children.

Disposal

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

Pharmaceutical precautions

Do not store above 25 °C. Protect from direct sunlight.

On occasions where only part of the paste is used, replace the cap and store as indicated.

Legal category

POM-VPS

Packaging Quantities

28.5 g plastic syringe in packs of 20.

Further information

Nil

Marketing authorisation number

Vm 12597/4041.

Significant Changes