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@jacgb.jnj.com

Presentation

White medicated premix containing flubendazole 5 % w/w (50 mg/g).

Uses

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

Dosage and administration

Standard dosing regime

Incorporation

Add 600 g of Flubenol premix to at least 5 kg of one of the feed ingredients and mix well. Thoroughly mix this premix with the remaining ingredients making in all one tonne of medicated feed, which can then be fed as mash or pellets. This gives 30 mg flubendazole per kg of finished feed. Breeding stock should be treated for 10 consecutive days. Weaners and fattening pigs should be treated for 5 consecutive days, or in the event of heavy Trichuris infestation, for 10 consecutive days.

Variable dosing regime

To facilitate feeding for different lengths of time to suit the intervals between feed deliveries, the standard dosage can be divided and administered over differing periods of time, as shown below.

Incorporation

Add the required amount of Flubenol premix to at least 5 kg of one of the feed ingredients and mix well. Thoroughly mix this premix with the remaining ingredients making in all one tonne of medicated feed, which can then be fed as mash or pellets.

Dosage

a) Breeding stock

Amount of Flubenol 5% to add to each 5 kg premix for making up each tonne of final feed	Flubendazole inclusion rate in final feed (mg/kg)	Duration of treatment (days)
400g 300g 200g	20 15 10	14 21 28
Uses Ascaris suum, Oesophagostomum dentatum and Hyostronglylus rubidus

b) Weaners and fattening pigs

Amount of Flubenol 5% to add to each 5 kg premix for making up each tonne of final feed	Flubendazole inclusion rate in final feed (mg/kg)	Duration of treatment (days)
200g 150g	10 7.5	14 21
Uses Ascaris suum, Oesophagostomum dentatum and Hyostronglylus rubidus

In the event of a heavy Trichuris infestation, use 600 g/tonne (30 mg/kg final feed) for 10 days.

Treatment frequency

Twice a year unless recommended otherwise by a veterinary surgeon. Treat the whole herd at the same time to minimise the risk of reinfestation. New arrivals should be treated on arrival and before mixing with other animals.

Treatment of clinical worm infestations

Consult a veterinary surgeon for initial identification of problem species. Treat relevant infestations at intervals shown below:

Lungworm: every 3–4 weeks.

Nodular worm: every 2 months.

Large roundworm: every 2 months.

Red stomach worm: every month.

Whipworm: every 6 weeks.

Contra-indications, warnings, etc

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

Withdrawal period

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.

Operator Warning

Accidental ingestion by humans should be avoided. Avoid direct skin contact. 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, either a half mask respirator (European Standard EN149) with disposable filter or a non-disposable respirator (European Standard EN140) fitted with a filter (EN143) should be worn.

Disposal

Dispose of empty containers in the farm refuse. Used containers should not be recycled.

Pharmaceutical precautions

Store in tightly closed original containers. Do not store above 25 °C. Flubenol 5% can be incorporated into pelleted feed preconditioned with steam for up to 5 minutes at temperatures of 77 °C and can withstand pelleting temperatures up to 116 °C. The product will remain stable in finished feed for up to 8 weeks.

Legal category

POM-VPS

Packaging Quantities

25 kg bag

Further information

Flubenol 5 % Premix may only be incorporated by approved manufacturers at the above incorporation rates.

Marketing authorisation number

Vm 00242/4017.