Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
FLORFENICOL
Elanco Europe Ltd
QJ01BA90
FLORFENICOL
23 Mg/Ml
Oral Solution
POM: Prescription Only Medicine as defined in relevant national legislation
Porcine
florfenicol
Antibacterial
Authorised
2016-06-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Florvio 23 mg/ml solution for use in drinking water for pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for use in drinking water. Clear, colourless to yellow, slightly viscous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pig. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and prevention at the group level where clinical signs are present of swine respiratory disease associated with_ Actinobacillus pleuropneumoniae_ and_ Pasteurella multocida_ susceptible to florfenicol. The presence of the disease should be established in the herd before initiating treatment. 4.3 CONTRAINDICATIONS Do not use in boars intended for breeding purposes. Do not administer in cases of previous allergic reactions to florfenicol. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The treated pigs should be placed under special observation. On each of the five days of treatment, untreated drinking water should not be given until the full daily amount of medicated drinking water has been ingested by the pigs. If there is no significant improvement after 3 treatment days, the diagnosis should be reviewed and if necessary the treatment should be changed. Each ml contains: ACTIVE SUBSTANCE: Florfenicol 23 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _7_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _3_ Baca dokumen lengkap