Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: VMD (Veterinary Medicines Directorate)
Enrofloxacin
Bayer plc
QJ01MA90
Enrofloxacin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Antimicrobial
Expired
2011-09-05
Revised: July 2016 AN: 01357/2015 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril Direct 100 mg/ml Injektionslösung für Schweine [AT] Baytril 1nject 100 mg/ml solution for injection for pigs [BE, LU, NL] Baytril Inject – Soluzione iniettabile 100mg/ml per suini [IT] Baytril Max 100 mg/ml solution for injection for pigs [IE, UK] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Enrofloxacin 100 mg EXCIPIENT(S): n-Butanol 30 mg Benzyl alcohol (E 1519) 20 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, yellow solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pig 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of bacterial bronchopneumonia caused by enrofloxacin- sensitive _Actinobacillus pleuropneumoniae_, _Pasteurella multocida _and complicated by _Haemophilus parasuis _as secondary pathogen in pigs. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in case of resistance against other fluoroquinolone due to the potential for cross-resistance. Do not use in animals with central nervous system-associated seizure disorders. Do not use in the presence of existing disorders of cartilage development or musculoskeletal damage around functionally significant or weight-bearing joints. Do not use for prophylaxis. Revised: July 2016 AN: 01357/2015 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Repeated injections should be administered at different sites. Official, national and regional antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on su Lesen Sie das vollständige Dokument