Country: Austria
Bahasa: Inggeris
Sumber: HMA (Heads of Medicines Agencies)
enrofloxacin 100 mg/ml
Bayer Austria GmbH
QJ01MA90
Solution for injection
enrofloxacin
Cattle, Pigs
2012-09-20
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 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 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 Baca dokumen lengkap