국가: 영국
언어: 영어
출처: VMD (Veterinary Medicines Directorate)
Enrofloxacin
Krka d.d., Novo Mesto
QJ01MA90
Enrofloxacin
Oral solution
POM-V - Prescription Only Medicine – Veterinarian
Chickens, Turkeys
Antimicrobial
Authorized
2005-09-09
Revised: June 2018 AN: 00219/2018 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ENROXIL 100 mg/ml oral solution for chickens and turkeys. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 1 ml of oral solution contains: enrofloxacin 100 mg. EXCIPIENT: Benzyl alcohol 14 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Clear, yellow solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Broilers, broiler breeders, replacement chickens, turkeys. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections caused by the following bacteria susceptible to enrofloxacin: CHICKENS _Mycoplasma gallisepticum,_ _Mycoplasma synoviae,_ _Avibacterium paragallinarum,_ _Pasteurella multocida._ TURKEY _Mycoplasma gallisepticum,_ _Mycoplasma synoviae,_ _Pasteurella multocida._ 4.3 CONTRAINDICATIONS Do not use for prophylaxis. Do not use when resistance / cross-resistance to (fluoro)quinolones is known to occur in the flock intended for treatment. Infections caused by _Streptococcus _spp., because of only marginal susceptibility to enrofloxacin. Do not use in other animals. Revised: June 2018 AN: 00219/2018 Page 2 of 6 Do not use in case of hypersensitivity to the active substance, or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Treatment of _Mycoplasma_ spp infections may not eradicate the organism. 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 only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effective 전체 문서 읽기