For treatment of adult fluke, immature and early immature stages of fluke worm.
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Endofluke 100 mg/ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
per ml
Triclabendazole
Excipients
100 mg
Methyl Parahydroxybenzoate(E218)
2 mg (preservative)
Propyl Parahydroxybenzoate (E216)
0.2 mg (preservative)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension.
A white to off-white suspension.
4 CLINICAL PARTICULARS
4.1 Target Species
Cattle & Sheep
4.2 Indications for use, specifying the target species
For the treatment of adult, immature and early immature stages of liver fluke (Fasciola hepatica) susceptible to triclabendazole.
4.3 Contraindications
Do not use in animals known to be hypersensitive to the active substance.
4.4 Special warnings for each target species
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 under estimation 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.
4.5 Special precautions for use
i) Special precautions for use in animals
Care should be taken when dosing animals to avoid causing injury to the mouth and pharynx. ii) 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.
iii) 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.
4.6 Adverse reactions (frequency and seriousness)
Occasionally, inflammation of the unpigmented skin, including the udder and the teats may occur after treatment in cattle exposed to intense sunshine.
4.7 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.
4.8 Interaction with other medicinal products and other forms of interaction
None known
4.9 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 12 mg triclabendazole per kg bodyweight in cattle and 10 mg triclabendazole per kg bodyweight in sheep.
Sheep: 1 ml per 10kg bodyweight
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 repeat administration of the product; animals should not be treated with a frequency of less than 10 weeks.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
4.11 Withdrawal Period(s)
Cattle (meat and offal): 56 days Milk:
Cattle (milk): Milk for human consumption may only be taken from 48 hours after calving. Not intended for use within 45 days of calving. Should a cow calve earlier than 45 days after the last treatment, milk for human consumption may only be taken from 45 days + 48 hours (47 days) after the last treatment.
Sheep (meat & offal): 56 days
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.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
ATCvet code: QP52AC01
Pharmacotherapeutic group: anthelmintics; benzimidazoles and related substances.
5.1 Pharmacodynamic properties
Triclabendazole differs from other benzimidazoles 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 dependant on microtubular functions. The precise molecular mode of action of this fasciolicidal drug remains to be elucidated.
5.2 Pharmacokinetic properties
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 approximately 27 hours after administration of the product and the sulfone reaches peak concentrations 64 to 72 hours after administration.
In sheep triclabendazole sulfoxide reaches peak concentrations approximately 20 hours after administration of the product and the sulfone reaches peak concentrations 30 to 32 hours after administration.
Both metabolites bind strongly to plasma proteins, particularly albumin.
Metabolites 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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Xanthan Gum
Methyl Parahydroxybenzoate
Propyl Parahydroxybenzoate
Citric Acid Anhydrous
Sodium Citrate
Polysorbate 80
Silica Colloidal
Anhydrous Simethicone Emulsion
Water, purified
6.2 Incompatibilities
None Known.
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
6.4 Special precautions for storage
Protect from frost.
6.5 Nature and composition of immediate packaging
1 litre, 2.5 litre, 5 litre and 3 x 5L high-density polyethylene flat bottom backpack containers containing a white to offwhite smooth suspension. The closures used for all 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.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
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
7 MARKETING AUTHORISATION HOLDER
Cross Vetpharm Group Ltd.
Broomhill Road,
Tallaght,
Dublin 24.
8 MARKETING AUTHORISATION NUMBER(S)
VPA 10960/046/001
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1st August 2002
Date of last renewal: 19th February 2008
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Endofluke 100 mg/ml Oral Suspension
|
Active Substance |
per ml |
|
Triclabendazole Excipients |
100 mg |
|
Methyl Parahydroxybenzoate(E218) |
2 mg (preservative) |
|
Propyl Parahydroxybenzoate (E216) |
0.2 mg (preservative) |
For a full list of excipients, see section 6.1.
Oral Suspension.
A white to off-white suspension.
4.1 Target Species
Cattle & Sheep
For the treatment of adult, immature and early immature stages of liver fluke (Fasciola hepatica) susceptible to triclabendazole.
4.3 Contraindications
Do not use in animals known to be hypersensitive to the active substance.
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:
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.
i) Special precautions for use in animals
Care should be taken when dosing animals to avoid causing injury to the mouth and pharynx. ii) 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.
iii) 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.
Occasionally, inflammation of the unpigmented skin, including the udder and the teats may occur after treatment in cattle exposed to intense sunshine.
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.
4.8 Interaction with other medicinal products and other forms of interaction
None known
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 12 mg triclabendazole per kg bodyweight in cattle and 10 mg triclabendazole per kg bodyweight in sheep.
Sheep: 1 ml per 10kg bodyweight
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 repeat administration of the product; animals should not be treated with a frequency of less than 10 weeks.
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.
Cattle (meat and offal): 56 days Milk:
Cattle (milk): Milk for human consumption may only be taken from 48 hours after calving. Not intended for use within 45 days of calving. Should a cow calve earlier than 45 days after the last treatment, milk for human consumption may only be taken from 45 days + 48 hours (47 days) after the last treatment.
Sheep (meat & offal): 56 days
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.
ATCvet code: QP52AC01
Pharmacotherapeutic group: anthelmintics; benzimidazoles and related substances.
Triclabendazole differs from other benzimidazoles 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 dependant on microtubular functions. The precise molecular mode of action of this fasciolicidal drug remains to be elucidated.
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 approximately 27 hours after administration of the product and the sulfone reaches peak concentrations 64 to 72 hours after administration.
In sheep triclabendazole sulfoxide reaches peak concentrations approximately 20 hours after administration of the product and the sulfone reaches peak concentrations 30 to 32 hours after administration.
Both metabolites bind strongly to plasma proteins, particularly albumin.
Metabolites 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.
Xanthan Gum
Methyl Parahydroxybenzoate
Propyl Parahydroxybenzoate
Citric Acid Anhydrous
Sodium Citrate
Polysorbate 80
Silica Colloidal
Anhydrous Simethicone Emulsion
Water, purified
6.2 Incompatibilities
None Known.
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
6.4 Special precautions for storage
Protect from frost.
1 litre, 2.5 litre, 5 litre and 3 x 5L high-density polyethylene flat bottom backpack containers containing a white to offwhite smooth suspension. The closures used for all 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.
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
Cross Vetpharm Group Ltd.
Broomhill Road,
Tallaght,
Dublin 24.
8 MARKETING AUTHORISATION NUMBER(S)
VPA 10960/046/001
Date of first authorisation: 1st August 2002
Date of last renewal: 19th February 2008
August 2016
August 2016
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