Pays: Allemagne
Langue: anglais
Source: HMA (Heads of Medicines Agencies)
florfenicol 500 mg/g
Intervet Intenational BV
QJ01BA90
Premix for medicated feed
florfenicol
Fish Food
2012-10-24
Page 1 of 15 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Aquaflor 500 mg/g premix for medicated feeding stuff for rainbow trouts Spain: Florocol Aqua 500 mg/g premix for medicated feeding stuff for rainbow trouts Finland: Aquaflor vet 500 mg/g premix for medicated feeding stuff for rainbow trouts 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g premix contains: ACTIVE SUBSTANCE: Florfenicol 500 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff. A white free flowing powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Rainbow trout (_Oncorhynchus mykiss_) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and prevention of furunculosis in rainbow trout caused by _Aeromonas salmonicida_ susceptible to florfenicol in freshwater fisheries. The presence of the disease should be established in the holding unit before initiating the treatment. Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. 4.3 CONTRAINDICATIONS Do not use in broodstock. Do not use in animals with known hypersensitivity to the active ingredient. Do not administer together with other antimicrobial products. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In order to maximize feed uptake throughout the population to be treated, medicated feed should be administered following the same feeding regimen as was used prior to treatment, to the greatest degree possible. Care should be taken when administering medicated fee Lire le document complet