Tribex 5 % Oral Suspension for Sheep

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Triclabendazole

Διαθέσιμο από:

Chanelle Pharmaceuticals Manufacturing Limited

Φαρμακολογική κατηγορία (ATC):

QP52AC01

INN (Διεθνής Όνομα):

Triclabendazole

Δοσολογία:

5 percent weight/volume

Φαρμακοτεχνική μορφή:

Oral suspension

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

triclabendazole

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2000-10-02

Αρχείο Π.Χ.Π.

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