Tribex 10 % Oral Suspension for Cattle

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Triclabendazole

Beszerezhető a:

Chanelle Pharmaceuticals Manufacturing Limited

ATC-kód:

QP52AC01

INN (nemzetközi neve):

Triclabendazole

Adagolás:

10 percent weight/volume

Gyógyszerészeti forma:

Oral suspension

Recept típusa:

POM: Prescription Only Medicine as defined in relevant national legislation

Terápiás terület:

triclabendazole

Engedélyezési státusz:

Authorised

Engedély dátuma:

2000-10-02

Termékjellemzők

Health Products Regulatory Authority
22 November 2018
CRN008PVZ
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
EXCIPIENTS(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:
Health Products Regulatory Authority
22 November 2018
CRN008PVZ
Page 2 of 6
• 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 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 abou