Țară: Italia
Limbă: engleză
Sursă: HMA (Heads of Medicines Agencies)
enrofloxacin 100 mg/ml
Bayer Animal Health
QJ01MA90
Solution for injection
enrofloxacin
Pigs Food
2012-02-26
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS (Based on the current SPC of the reference product Baytril RSI 100 mg/ml Injektionslösung für Rinder und Schweine) 2 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 1nject-10%, solution injectabile [FR] Baytril 1nject 100 mg/ml Injektionslösung für Schweine [DE] 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 20 mg For a 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 the presence of documented hypersensitivity to the pharmacologically active ingredient or to any of the other ingredients. 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. 4.4 SPECIAL Citiți documentul complet