Nazione: Regno Unito
Lingua: inglese
Fonte: VMD (Veterinary Medicines Directorate)
Enrofloxacin
Bayer plc
QJ01MA90
Enrofloxacin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs
Antimicrobial
Authorized
2012-11-13
Revised: September 2020 AN: 00778/2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril Direct 100 mg/ml Injektionslösung für Rinder und Schweine [AT] Baytril Inject – Soluzione iniettabile 100mg/ml per bovini e suini [IT] Baytril XM 100 mg/mL Solution injectable pour bovins et porcs [FR] Baytril 1nject 100 mg/ml Injektionslösung für Rinder und Schweine [DE] Baytril Max 100 mg/ml Solution for Injection for Cattle and Pigs [IE, UK] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Enrofloxacin 100 mg EXCIPIENTS: 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 Cattle, Pig 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: For the treatment of respiratory tract infections caused by enrofloxacin-sensitive _Histophilus _ _somni,_ _ _ _Mannheimia _ _haemolytica,_ _ _ _Pasteurella _ _multocida_ _ _and _Mycoplasma _spp. For the treatment of mastitis caused by enrofloxacin-sensitive _E. coli_. Pig: For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive _Actinobacillus pleuropneumoniae_, _Pasteurella multocida_ and complicated by _Haemophilus parasuis _as a secondary pathogen_ _in pigs._ _ Page 1 of 8 Revised: September 2020 AN: 00778/2020 4.3 CONTRAINDICATIONS Do not use for prophylaxis. Do not use in cases of hypersensitivity to the active substance or to any of the excipients_._Do not use in known cases of resistance to other (fluoro)quinolones 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals For repeated inj Leggi il documento completo