País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
TRICLABENDAZOLE
Chanelle Animal Health Ltd.
QP52AC01
TRICLABENDAZOLE
5 %w/v
Oral Suspension
LM-Licensed Merchant
Ovine
Triclabendazole
Endoparasiticide
Authorised
2000-10-02
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 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 01/07/2015_ _CRN 7021047_ _page number: 1_ 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. Anthelmintics are agents that destroy or result in the expulsion of susceptible parasitic worms. Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. To reduce this risk, dosing programmes should be discussed with a Leia o documento completo