Tribex 10% Oral Suspension for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Triclabendazole

Available from:

Chanelle Animal Health Ltd

ATC code:

QP52ACOI

INN (International Name):

Triclabendazole

Pharmaceutical form:

Oral suspension

Prescription type:

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

Therapeutic group:

Cattle

Therapeutic area:

Anthelmintic flukicide

Authorization status:

Authorized

Authorization date:

2002-06-20

Summary of Product characteristics

Revised: October 2018
AN: 00486/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tribex 10% Oral Suspension for Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCE:
Triclabendazole
100 mg
EXCIPIENT(S):
Methyl Parahydroxybenzoate (E218)
2.0 mg
Propyl Parahydroxybenzoate (E216)
0.2 mg
Carmoisine supra (EB122)
22.5 microgram
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
An aqueous pink-coloured suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the treatment of acute, sub-acute and
chronic fasciolosis
in cattle caused by early immature, immature and adult stages of
liverfluke _(Fasciola _
_hepatica) _susceptible to triclabendazole.
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active ingredient
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 body weight,
misadministration of the product or lack of calibration of the dosing
device (if any).
Revised: October 2018
AN: 00486/2018
Page 2 of 6
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.
Therefore, the use of this product should be based on local
epidemiological
information about susceptibility of the _Fasciola hepatica_ and