Triclacert 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:

2007-07-11

Summary of Product characteristics

Revised: August 2020
AN: 00514/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Triclacert 5% Oral Suspension for Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Each ml contains 50mg Triclabendazole
ADJUVANT(S): N/A
EXCIPIENT(S): Each ml contains:
2.0mg Methyl Parahydroxybenzoate (E218)
0.2mg Propyl Parahydroxybenzoate (E216)
17.5 microgram Brilliant Blue (E133).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
Description: An aqueous blue-coloured suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Triclaben 5% is indicated for the treatment of 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).
Revised: August 2020
AN: 00514/2020
Page 2 of 5
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 sheep.
Therefore, the use of this product should be based on local (regional
/ farm)
epidemiological information about susceptibility of t