País: Regne Unit
Idioma: anglès
Font: VMD (Veterinary Medicines Directorate)
Triclabendazole
Elanco Europe Ltd
QP52AC01
Triclabendazole
Oral suspension
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Cattle, Sheep
Anthelmintic flukicide
Expired
2008-01-23
Revised: December 2015 AN. 01134/2015 Page 1 of 7 SUMMARY OF PRODUCTS CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fasinex 100 10%(w/v) Oral Suspension for Cattle & Sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative composition Active substance: Triclabendazole Excipient(s): Antimicrobial preservatives: Methyl hydroxybenzoate (E218) Propyl hydroxybenzoate (E216) Benzoic acid (E210) Quantitative composition 10.000% w/v 0.110% w/v 0.024% w/v 0.100% w/v For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension. A cream-coloured aqueous suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and Sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE For the treatment and control of liver fluke infections in cattle caused by all stages of triclabendazole-susceptible _Fasciola hepatica_ from 2 week old immature to adult fluke. SHEEP For the treatment and control of liver fluke infections in sheep caused by all stages of triclabendazole susceptible _Fasciola hepatica_ from 2 day old immature to adult fluke. 4.3 CONTRAINDICATIONS None known. Revised: December 2015 AN. 01134/2015 Page 2 of 7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Shake the container thoroughly before use. Assess bodyweight as accurately as possible before calculating dose. Intensive use or misuse of anthelmintics can give rise to resistance. To reduce this risk, dosing programmes should be discussed with your veterinary adviser. Efficacy of this product against liver fluke is reduced if triclabendazole-resistant strains are present. 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. Underdosing, which may be due to underestimation of bodyweight, misadministration of the product, or lack of calibration of the dosing device (if any). Suspected clinical cases Llegiu el document complet