Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Bayer Limited
QJ01MA90
ENROFLOXACIN
100 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Enrofloxacin
Antibacterial
Authorised
2012-11-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril Max 100 mg/ml Solution for Injection for Cattle and Pigs 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 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 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 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 WARNINGS FOR EACH TARGET SPECIES Do not use in case of resistance against other fluoroquinolone due to the potential for cross-resistance. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/11/2012_ _CRN 7011798_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS For repeated Read the complete document