Introduction

vet06701

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

White powder containing flubendazole 5 % w/w (50 mg/g) in a 600 g tub.

Uses

Flubendazole is a broad spectrum anthelmintic for oral administration, effective against mature and immature stages of the following nematodes of the gastro–intestinal tract of the pig: Ascaris suum (large roundworm) including migrating larvae, Hyostrongylus rubidus (red stomach worm), Oesophagostomum dentatum (nodular worm) and Trichuris suis (whipworm) and Strongyloides ransomi (threadworm - adult). Flubendazole is ovicidal.

Dosage and administration

To ensure administration of a correct dose, body weight should be determined as accurately as possible.

If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing.

1. Individual treatment (Single administration): Add 1 g of Flubenol for each 10 kg bodyweight onto the finished feed, as a single animal dose. (This is equivalent to 5 mg of flubendazole per one kg bodyweight). One 13 g measuring spoon treats one 130 kg sow.

2. Treatment frequency: Twice a year unless recommended otherwise by a veterinary surgeon. Pigs brought onto the premises should be treated on arrival and before mixing with other animals. Regular faecal examination is advocated to know which worms are present on the farm so that specific measures may be taken to prevent re-infection.

3. Treatment of clinical worm infestations: Treat relevant infestations at intervals shown below:

Nodular worm: every 2 months.

Large roundworm: every 2 months.

Red stomach worm: every month.

Whipworm: every 6 weeks.

Contra-indications, warnings, etc

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

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.

Accidental ingestion by humans should be avoided. May cause sensitisation by skin contact. May cause skin and eye irritation. Wear overalls, safety glasses and impervious gloves when mixing and handling the product. Wash affected parts if skin contact occurs. If accidental eye contact occurs, immediately rinse thoroughly with water. If the operation involves potential exposure to dust, wear either a disposable filter on a half mask respirator (conforming to European Standard EN149) or a non-disposable respirator (to European Standard EN140) fitted with a filter (EN143.

Withdrawal periods

Animals must not be slaughtered for human consumption during treatment. Pigs may be slaughtered for human consumption only after 7 days from the last treatment.

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