Introduction

Company name: Bimeda

Address: A division of Cross Vetpharm Group UK Limited

Bryn Cefni Industrial Park,

Llangefni,

Anglesey LL77 7XA.

Telephone: 0800 526769

Fax: 01248 725416

Email: sales@bimeda.co.uk

Presentation

Oral suspension containing 10% w/v triclabendazole.

Uses

For the treatment of adult, immature and early immature stages of liver fluke (Fasciola hepatica) susceptible to triclabendazole.

Dosage and administration

For oral administration only using properly calibrated dosing equipment. Estimate bodyweight accurately. Shake the container before use. Use unaltered from original container. Clean drenching equipment before and after use.

Dosage:

Endofluke 10 is given as an oral drench and is suitable for most types of automatic drenching guns. Endofluke 10 is to be used as a single administration. The recommended dose rate is 12mg active ingredient per kg bodyweight.

Practical Dosage Guide: 6 ml per 50kg bodyweight

Dose of Endofluke 10 for each animal weight:

50kg	6ml
100kg	12ml
150kg	18ml
200kg	24ml
250kg	30ml
300kg	36ml
350kg	42ml
400kg	48ml

For each additional 50kg add 6ml

The timing for re-treatment should be based on epidemiological risk patterns and should be customised for each individual farm.

The same treatment dates should be used for cattle and sheep when a liver fluke dosing programme is implemented and they are grazing the same pasture concurrently; an appropriate authorised product should be used in sheep.

An early spring treatment accompanied by summer treatments may prevent the flukes entering the lymnaeid snail as intermediate hosts and so the life cycle can be broken. A lasting result, however, can only be expected by involving all potential hosts (domestic ruminants, horse, game animals) in an extensive control programme.

Bought in cattle: All bought in animals, suspected to be infected with liver fluke, should be dosed before joining the main herd.

Housed cattle: Dose in the autumn or shortly after housing. Dosing is recommended before pasturing in order to prevent contamination of the pasture with liver fluke eggs.

Acute outbreaks: All animals should be treated immediately after diagnosis of acute fasciolosis.

Precautions During Administration:

When using, do not eat, drink or smoke. Wash splashes from eyes and skin immediately. Take off immediately any contaminated clothing. Wash hands and exposed skin before meals and after use.

Contra-indications, warnings, etc

Do not use in animals known to be hypersensitive to the active substance.

Careful estimation of bodyweight should be made.

Care should be taken when dosing animals to avoid causing injury to the mouth and pharynx.

Intensive use or misuse of anthelmintics can give rise to resistance. To reduce this risk, dosing programmes should be discussed with your Veterinary Surgeon.

Only use in liver fluke strains susceptible to Triclabendazole.

The use of Endofluke 10 may have harmful effects on fish and aquatic invertebrates. Cattle must not have any access to the surface water within 7 days after treatment with Endofluke 10. When spreading manure from treated animals on arable lands a safety distance of 10m to adjacent surface waters must be kept.

To avoid the potential for the accumulation of residues following repeat administration of Endofluke 10; animals should not be treated with a frequency of less than 10 weeks.

Undesirable effects:

Occasionally, inflammation of the unpigmented skin, including the udder and the teats may occur after treatment in cattle exposed to intense sunshine.

Overdose:

A single oral dose of 150-200 mg triclabendazole/kg of live bodyweight may lead to side effects such as unsteady gait, dullness and reduced appetite. These side effects are slight and last 1 to 5 days. An antidote is not known.

Use during pregnancy and lactation:

Endofluke 10 for cattle can be administered at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. Do not use in lactating animals producing milk for human consumption. Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.

Pharmaceutical precautions

Protect from frost.

Endofluke 10 may have toxic effects on fish and aquatic invertebrates. Any unused product or waste material must not enter surface water and should be disposed of in accordance with national requirements.

Legal category

POM-VPS

Packaging Quantities

1 and 2.5 litre backpack containers.

Further information

Nil

Marketing authorisation number

Vm 12597/4037.