Endofluke 100 mg/ml Oral Suspension

País: Reino Unido

Idioma: inglés

Fuente: VMD (Veterinary Medicines Directorate)

Ingredientes activos:

Triclabendazole

Disponible desde:

Cross Vetpharm Group Ltd

Código ATC:

QP52ACO1

Designación común internacional (DCI):

Triclabendazole

formulario farmacéutico:

Oral suspension

tipo de receta:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Grupo terapéutico:

Cattle, Sheep

Área terapéutica:

Anthelmintic flukicide

Estado de Autorización:

Authorized

Fecha de autorización:

2003-02-20

Ficha técnica

Revised: August 2017
AN: 00085/2017
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 100mg
EXCIPIENTS:
Methyl Parahydroxybenzoate (E218)
2mg (preservative)
Propyl Parahydroxybenzoate (E216)
0.2mg (preservative)
For the 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 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
Page 1 of 6
Revised: August 2017
AN: 00085/2017
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 PRE