Fasinex 240, 24% w/v Oral Suspension for Cattle

País: Regne Unit

Idioma: anglès

Font: VMD (Veterinary Medicines Directorate)

ingredients actius:

Triclabendazole

Disponible des:

Elanco Europe Ltd

Codi ATC:

QP52AC01

Designació comuna internacional (DCI):

Triclabendazole

formulario farmacéutico:

Oral suspension

tipo de receta:

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

Grupo terapéutico:

Cattle

Área terapéutica:

Anthelmintic flukicide

Estat d'Autorització:

Authorized

Data d'autorització:

2008-08-05

Fitxa tècnica

Revised: September 2020
AN: 00756/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasinex 240, 24% w/v Oral Suspension for Cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the product contains:
ACTIVE SUBSTANCE:
Triclabendazole 240 mg
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
1.1 mg
Propyl parahydroxybenzoate (E216)
0.4 mg
Benzyl alcohol (E1519)
5.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Suspension.
Cream-coloured aqueous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of acute, subacute and chronic infection due to
early
immature, immature, and mature stages of Fasciola hepatica. If
infected
animals are treated before disease has developed, fasciolosis can be
prevented.
4.3
CONTRAINDICATIONS
None known.
Revised: September 2020
AN: 00756/2020
Page 2 of 5
4.4
SPECIAL WARNINGS
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.
•
Underdosing, 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, and 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 a
number of countries including ones in the EU. Therefore the use of
this
product should be based on local epidemiological information about
susceptibility of F. hepatica and recommendations on how to limit
further