Tribex 5% Oral Suspension for Sheep

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:

5 percent weight/volume

Pharmaceutical form:

Oral suspension

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Sheep

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 5% Oral Suspension for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Each ml contains 50mg Triclabendazole
EXCIPIENT(S): Each ml contains: 2.0mg Methyl Parahydroxybenzoate
(E2I8)
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
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
None
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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 c