Endofluke 100 mg/ml Oral Suspension

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Triclabendazole

Disponible des:

Bimeda Animal Health Limited

Codi ATC:

QP52AC01

Designació comuna internacional (DCI):

Triclabendazole

Dosis:

100 milligram(s)/millilitre

formulario farmacéutico:

Oral suspension

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

triclabendazole

Estat d'Autorització:

Authorised

Data d'autorització:

2002-08-01

Fitxa tècnica

Health Products Regulatory Authority
28 June 2019
CRN00956L
Page 1 of 5
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
​100
​mg
​
​
​
​
Excipients
​
​
​
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 l