Tribex 5% Oral Suspension for Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Triclabendazole

Available from:

Chanelle Animal Health Ltd

ATC code:

QP52AC01

INN (International Name):

Triclabendazole

Pharmaceutical form:

Oral suspension

Prescription type:

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

Therapeutic group:

Sheep

Therapeutic area:

Anthelmintic flukicide

Authorization status:

Authorized

Authorization date:

2002-06-20

Summary of Product characteristics

Revised: July 2018
AN: 01969/2017
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tribex 5% Oral Suspension for Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Triclabendazole
50mg
EXCIPIENT(S): Each ml contains:
Methyl Parahydroxybenzoate (E218)
2.0 mg
Propyl Parahydroxybenzoate (E216)
0.2 mg
Brilliant Blue (E133)
17.5 microgram
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
An aqueous blue-coloured suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the treatment of acute, sub-acute and
chronic fasciolosis
in sheep 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).
Suspected clinical cases of resistance to anthelmintics should be
further investigated
using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where
the results
Revised: July 2018
AN: 01969/2017
Page 2 of 5
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 sheep.
Therefore, the use of this product should be based on local (regional
/ farm)
epidemiological information about susceptibility of the