Enroxil Flavour 15 mg tablets

Country: Afrika Selatan

Bahasa: Inggeris

Sumber: South African Health Products Regulatory Authority (SAHPRA)

Boleh didapati daripada:

Biotech Laboratories (Pty) Ltd

Dos:

15 mg

Borang farmaseutikal:

Tablet

Komposisi:

Each 1.0 ml contains: enrofloxacin 15.0 mg

Kawasan terapeutik:

C 17.1.6 Antimicrobials (quinolones)

Status kebenaran:

Registered

Ciri produk

BIOTECH LABORATORIES (PTY) LTD
ENROXIL FLAVOUR TABLETS
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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
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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