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Date: Friday, April 26, 2024 2:26

Description: Bimeda logo
Release 3.18
Endofluke 100 mg/ml Oral Suspension
 
Species: Sheep, Cattle
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Flukicides
Active ingredient: Triclabendazole
Product:Endofluke 100 mg/ml Oral Suspension
Product index: Endofluke 100 mg/ml Oral Suspension
Cattle - milk: See notes
Cattle - meat: 56 days
Sheep - meat: 56 days
Withdrawal notes: Cattle Milk: may only be taken from 48 hours after calving. Not intended for use within 45 days of calving. If calving occurs before 45 days after treatment, milk for human consumption may only be 45 days plus 48 hours after the treatment. Sheep Milk: Not authorised for use in ewes producing milk for human consumption including during the dry period. Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.
Incorporating:
Qualitative and quantitative composition
Active Substance per ml
Triclabendazole 100mg
Pharmaceutical form
A white to off-white oral suspension.
Clinical particulars
Target species
Cattle & Sheep.
Indications for use
For the treatment of adult, immature and early immature stages of liver fluke (Fasciola hepatica) susceptible to triclabendazole.
Contra-indications
Do not use in animals known to be hypersensitive to the active substance.
Special precautions for use in animals
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. Under dosing, which may be due to underestimation of bodyweight, 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 triclabendazole has been reported in Fasciola hepatica in cattle and sheep.Therefore, the use of this product should be based on local (regional/farm) epidemiological information about susceptibility of the Fasciola hepatica and recommendations on how to limit further selection for resistance to anthelmintics.
Care should be taken when dosing animals to avoid causing injury to the mouth and pharynx.
Special Precautions to be taken by the person administering the product to animals
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.
Other precautions
The use of this product may have harmful effects on fish and aquatic invertebrates. Cattle and sheep must not have any access to the surface water such as streams, ponds or ditches within 7 days after treatment. When spreading manure from treated animals on arable lands, a safety distance of 10m to adjacent surface waters must be kept.
Adverse reactions
Occasionally, inflammation of the unpigmented skin, including the udder and the teats may occur after treatment in cattle exposed to intense sunshine.
Use during pregnancy, lactation or lay
The product is safe for use during pregnancy and lactation. However, the product is not permitted for use during lactation in animals producing milk for human consumption (see withdrawal periods).
Interactions
None known.
Amounts to be administered and administration route
For single oral administration only using properly calibrated dosing equipment. The product is suitable for most types of automatic drenching guns.
Shake the container before use.
Use unaltered from original container.
Clean drenching equipment before and after use.
Dosage:
Endofluke 100 mg/ml is given as an oral drench and is suitable for most types of automatic drenching guns.
The recommended dose rate is 12mg triclabendazole per kg bodyweight in cattle and 10mg triclabendazole per kg bodyweight in sheep.
Cattle Dosage Guide: Endofluke 100 mg/ml Oral Suspension
Practical Dosage Guide: Cattle: 6ml per 50 kg bodyweight
Animal Weight
Dose of Product
50kg
6ml
100kg
12ml
150kg
18ml
200kg
24ml
250kg
30ml
300kg
36ml
350kg
42ml
400kg
48ml
Free each additional 50kg
6ml
Sheep: 1 ml per 10kg bodyweight
Sheep Dosage Guide: Endofluke 100 mg/ml Oral Suspension
Practical Dosage Guide: Sheep: 1ml per 10kg bodyweight
Animal Weight
Dose of product
10kg
1ml
20kg
2ml
30kg
3ml
40kg
4ml
50kg
5ml
60kg
6ml
For each additional 10kg
1ml
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.
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.
The timing for re-treatment should be based on epidemiological risk patterns and should be customised for each individual farm.
To avoid the potential for the accumulation of residues following repeatadministration of the product; animals should not be treated with a frequency of less than 10 weeks.
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.
Withdrawal periods
Cattle and sheep meat and offal: 56 days
Cattle: Milk for human consumption: Milk may only be taken from 48 hours after calving. Not intended for use within 45 days of calving. If calving occurs before 45 days after treatment, milk for human consumption may only be taken after day 45 plus 48 hours after the treatment.
Sheep Milk: Not authorised for use in ewes producing milk for human consumption including during the dry period. Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: anthelmintics; benzimidazoles and related substances. ATC vet code: QP52ACO1.
Pharmacodynamic properties
Triclabendazole differs from other benzinidazoles in that it is a narrow spectrum anthelmintic. The drug accumulates significantly in both immature and adult stages of Fasciola hepatica and stimulates the major routes of the parasite's energy generating system, as demonstrated by glucose derived acetate and propionate formation. However under these conditions the parasite's motility decreased, indicating that the drug is not associated with inhibition of the energy generating pathways.
Triclabendazole inhibits colchicine binding to microtubular proteins suggesting interference of the drug with microtubular structure and function. The drug strongly inhibits the release of proteolytic enzymes in immature and adult parasites, a process dependent on microtubular functions. The precise molecular mode of this fasciolicidal drug remains to be elucidated.
Pharmacokinetic particulars
50-75% of the orally administered dose of triclabendazole is absorbed from the gastrointestinal tract. Very rapidly, absorbed triclabendazole is almost completely oxidised to its sulfoxide and sulfone. In cattle triclabendazole sulfoxide reaches peak concentrations 64-72 hours after administration of the product and the sulfone reaches peak concentrations 64-72 hours after administration. In sheep triclabendazole sulfoxide reaches peal concentrations approximately 20 hours after administration of the product and the sulfone reaches peak concentrations 30-32 hours after administration. Both metabolites bind strongly to plasma proteins, particularly albumin. Metabolities are excreted via the bile mainly as conjugates. More than 90-95% of the total dose of triclabendazole is excreted in the faeces, about 2% in the urine and less than 1% in the milk. The elimination is virtually complete by 10 days after administration.
Pharmaceutical particulars
List of excipients
Xanthan Gum
Methyl Parahydroxybenzoate
Propyl Parahydroxbenzoate
Citric Acid Anhydrous
Sodium Citrate
Polysorbate 80
Silica Colloidal
Anhydrous Simethicone Emulsion
Water, purified
Major incompatibilities
None Known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Protect from frost.
Immediate packaging
1 litre and 2.5 litre high-density polyethylene flat bottom backpack containers containing a white to off-white smooth suspension. The closures used for both pack sizes are 38 mm propylene standard caps with an induction heat seal liner. A 38 mm polypropylene spouted cap is also provided with each pack size for dispensing purposes.
Disposal
The product 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.
Marketing Authorisation Number
Vm 50146/4018
Significant changes
Date of the first authorisation or date of renewal
Date: 20th February, 2003
Date of revision of the text
Date: October 2018
Any other information
Nil
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Endofluke 10% 2.5L
GTIN:5391510231080
GTIN description:Endofluke 10% 5L
GTIN:5391510233909