국가: 남아프리카
언어: 영어
출처: South African Health Products Regulatory Authority (SAHPRA)
Biotech Laboratories (Pty) Ltd
15 mg
Tablet
Each 1.0 ml contains: enrofloxacin 15.0 mg
C 17.1.6 Antimicrobials (quinolones)
Registered
BIOTECH LABORATORIES (PTY) LTD ENROXIL FLAVOUR TABLETS Page 1 of 8 PROPOSED PACKAGE INSERT FOR ENROXIL FLAVOUR TABLETS VETERINARY MEDICINE SCHEDULING STATUS S4 PROPRIETARY NAME AND DOSAGE FORM Enroxil Flavour 15 mg tablets Enroxil Flavour 50 mg tablets Enroxil Flavour 150 mg tablets COMPOSITION ACTIVE INGREDIENT: Enroxil Flavour 15 mg: Each tablet contains 15 mg enrofloxacin. Enroxil Flavour 50 mg: Each tablet contains 50 mg enrofloxacin. Enroxil Flavour 150 mg: Each tablet contains 150 mg enrofloxacin. OTHER INGREDIENTS: Mannitol, maize starch, sodium starch glycolate, meat flavour 10022, basic butylated methacrylate copolymer, sodium laurilsulfate, dibutyl sebacate, croscarmellose sodium, silica (colloidal anhydrous), talc, magnesium stearate PHARMACOLOGICAL CLASSIFICATION C 17.1.6 Antimicrobials (quinolones) PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES: Enrofloxacin is bactericidal in action with activity against Gram-positive and Gram-negative BIOTECH LABORATORIES (PTY) LTD ENROXIL FLAVOUR TABLETS Page 2 of 8 bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials – they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the super coiling of bacterial DNA during replication. Resealing of the double standard helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phosholipid cell wall. Susceptibility of selected target pathogens minimum inhibitory concentration (MIC) is as follows: • _Pasteurella multocida:_ 0,03 mg/L; • _Escherichia coli:_ 0,03 – 0,06 mg/L; • _Staphylococcus pseudointermedius:_ 0,125 mg/L; • _Pseudomonas aeruginosa: _2,0 mg/L. Susceptibility breakpoints are: sensitive ≤ 0,5 mg/L; intermediate 1 – 2 mg/L; resistant ≥ 4 mg/L. Bacterial resistance to fluoroquinolones most frequently occurs by alteration of the target, enzyme DNA gyr 전체 문서 읽기