Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
TRICLABENDAZOLE
Chanelle Animal Health Ltd.
QP52AC01
TRICLABENDAZOLE
10 Per Cent
Oral Suspension
LM-Licensed Merchant
Bovine
Triclabendazole
Endoparasiticide
Authorised
2000-10-02
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. 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. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS. When using the product do not eat, drink or smoke, Wear gloves. Wash splashes from eyes and skin immediately. Take off any contaminated clothing immediately. Wash hands and exposed skin before meals and after wo Lue koko asiakirja