Pays: Roumanie
Langue: anglais
Source: HMA (Heads of Medicines Agencies)
florfenicol 40 mg/g
Krka d.d.
QJ01BA90
Oral powder
florfenicol
Pigs
2013-01-23
Issued: April 2013 AN: 00140/2012 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Floron 40 mg/g Oral powder for Swine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBSTANCE: Florfenicol 40 mg EXCIPIENTS: Propylene Glycol (E1520) 10 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral powder. Slightly brownish white powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pig (fattening pigs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In fattening pigs: For the treatment of swine respiratory disease in individual pigs due to_ Pasteurella _ _multocida_ susceptible to florfenicol. 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 food should not be given until the full daily amount of medicated feed has been ingested by the pigs. Issued: April 2013 AN: 00140/2012 Page 2 of 5 If there is no significant improvement after 3 treatment days, the diagnosis should be reviewed and if necessary the treatment should be changed. Animals showing a decreased appetite and/or a poor general condition should be treated by the parenteral route. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS The product should be used in conjunction with susceptibi Lire le document complet