Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Triclabendazole
Elanco Europe Ltd
QP52AC
Triclabendazole
5 percent weight/volume
Oral suspension
LM: Licensed Merchant as defined in relevant national legislation
Sheep
Benzimidazoles and related substances
Endoparasiticide
Authorised
2016-10-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Fasinex 5% w/v Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension. White to cream-coloured suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Ovines. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and control of adult, immature and early immature stages of liver fluke susceptible to triclabendazole. Target Species:_ Fasciola hepatica_. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active substance. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 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. Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the tests strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used. Each ml contains: ACTIVE SUBSTANCE Triclabendazole 50 mg EXCIPIENTS Methyl Parahydroxybenzoate (E218) 1.1 mg Propyl Parahydroxybenzoate (E216) 0.24 mg Benzoic Acid (E210) 1.0 mg H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Olvassa el a teljes dokumentumot