Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Enrofloxacin
Krka d.d., Novo Mesto
QJ01MA90
Enrofloxacin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs
Antimicrobial
Authorized
2013-11-28
Revised: July 2018 AN: 02164/2017 Page 1 of 6 SUMMARY OF PRODCUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrox Max 100 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin 100 mg EXCIPIENTS: Benzyl alcohol (E1519) 20 mg Butyl alcohol 30 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 and pigs. 4.2 INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES Cattle: For the treatment of respiratory tract infections caused by enrofloxacin-susceptible _Histophilus somni, Mannheimia haemolytica, Pasteurella multocida, _and _Mycoplasma_ spp. For the treatment of mastitis caused by enrofloxacin-susceptible _E. coli_. Pigs: For the treatment of bacterial bronchopneumonia caused by enrofloxacin-susceptible _Actinobacillus pleuropneumoniae, Pasteurella multocida _and complicated by _Haemophilus parasuis _as secondary pathogen_ _in pigs. 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 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. Revised: July 2018 AN: 02164/2017 Page 2 of 6 Do not use in known cases of resistance against other (fluoro)quinolones due to the potential for cross-resistance. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Official and local 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 o Read the complete document