Země: Rakousko
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
enrofloxacin 100 mg/ml
Bayer HealthCare
QJ01MA90
Solution for injection
enrofloxacin
Cattle Food, Pigs
2011-12-21
_[Version 8, 10/2012] _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril One 100 mg/ml solution for injection for cattle and pig (PT, PL, AT) Baytriluno 100 mg/ml solution for injection for cattle and pig (ES) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE INGREDIENT: Enrofloxacin 100 mg EXCIPIENTS: 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., as well as treatment of colimastitis. Pigs: For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive _Actinobacillus pleuropneumoniae_, _Haemophilus parasuis _and_ Pasteurella multocida_. _ _ 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with central nervous system-associated seizure disorders, existing impairment of cartilage growth or damage to the locomotor apparatus involving joints subjected to heavy functional stresses or load-bearing joints. Do not use in case of existing resistance against quinolones as this resistanc Přečtěte si celý dokument
_[Version 8, 10/2012] _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril One 100 mg/ml solution for injection for cattle and pig (PT, PL, AT) Baytriluno 100 mg/ml solution for injection for cattle and pig (ES) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE INGREDIENT: Enrofloxacin 100 mg EXCIPIENTS: 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., as well as treatment of colimastitis. Pigs: For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive _Actinobacillus pleuropneumoniae_, _Haemophilus parasuis _and_ Pasteurella multocida_. _ _ 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with central nervous system-associated seizure disorders, existing impairment of cartilage growth or damage to the locomotor apparatus involving joints subjected to heavy functional stresses or load-bearing joints. Do not use in case of existing resistance against quinolones as this resistanc Přečtěte si celý dokument