Tribex 10% Oral Suspension for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Triclabendazole

Available from:

Chanelle Animal Health Ltd.

ATC code:

QP52AC01

INN (International Name):

Triclabendazole

Dosage:

10 percent weight/volume

Pharmaceutical form:

Oral suspension

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

triclabendazole

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2000-10-02

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tribex 10% Oral Suspension for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
None
Each ml contains
ACTIVE SUBSTANCE:
Triclabendazole
100 mg
EXCIPIENTS(S):
Methyl Parahydroxybenzoate (E2I8)
2.0
mg
Propyl Parahydroxybenzoate (E216)
0.2
mg
Carmoisine supra (EB122).
22.5 mg
For a full list of excipients, see section 6.
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS.
Only use for liver fluke strains susceptible to triclabendazole.
Frequent and repeated use may lead to the development
of resistance. Care must be taken not to damage the mouth or
pharyngeal region when dosing. Clean drenching
equipment before and after use. Use unaltered product from the
original container.
SPEC