Tribex 5 % Oral Suspension for Sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Triclabendazole

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP52AC01

INN (International Name):

Triclabendazole

Dosage:

5 percent weight/volume

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

triclabendazole

Authorization status:

Authorised

Authorization date:

2000-10-02

Summary of Product characteristics

Health Products Regulatory Authority
22 November 2018
CRN008PVZ
Page 1 of 6
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.
Health Products Regulatory Authority
22 November 2018
CRN008PVZ
Page 2 of 6
• 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 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)
e