HIPRALONA ENRO-S (Enrofloxacin 100 mgml oral solution)

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Thành phần hoạt chất:

ENROFLOXACIN

Sẵn có từ:

Hipra Malaysia Sdn Bhd

INN (Tên quốc tế):

ENROFLOXACIN

Các đơn vị trong gói:

1000.00 mcg/mL; 100.00 mcg/mL; 5000.00 mcg/mL

Sản xuất bởi:

Laboratorios Hipra, S.A.

Đặc tính sản phẩm

706727-02.0
02-18
HIPRALONA ENRO-S
Enrofloxacin 100 mg/ml oral solution
COMPOSITION PER ML:
Enrofloxacin 100 mg.
Clear solution slightly yellowish.
PHARMACODYNAMICS:
Enrofloxacin is an antibiotic that pertains to the chemical class
of fluoroquinolones. The compound exercises a bactericidal
activity by a mechanism of action based on inhibition of the A
subunit
of
the
bacterial
DNA
gyrase
(Topoisomerase
II),
impeding the negative axial rotation of the DNA molecule. The
main
target,
in
Gram-positive
bacteria
would
be
the
Topoisomerase
IV
instead
of
the
Topoisomerase
II.
The
processes
of
replication,
transcription
and
bacterial
DNA
recombination
are
blocked
by
this
mechanism.
The
fluoroquinolones also act on bacteria in the stationary phase by
altering the permeability of the phospholipidic layer of the
exterior membrane of the cell wall.
These mechanisms explain the rapid loss of viability of the bacteria
exposed to enrofloxacin.
The inhibitory and bactericidal concentrations of enrofloxacin are
strongly correlated. They are
either the same or at most differ by 1 or 2 steps of dissolution in
concentration.
Enrofloxacin exercises antimicrobial activity at low concentrations
against the majority of
Gram-negative bacteria and many Gram-positive ones, both those that
are aerobic as well as
anaerobic.
Antibacterial spectrum:
Germ: _Escherichia coli_, _Salmonella spp._, _Pasteurella spp._,
_Mycoplasma spp._.
Critical concentration (breakpoints) of sensitivity (S) and resistance
(R), in µg/ml: (Source:
NCCLS 2000):
- _Staphylococcus spp._
≤ 1 2 ≥ 4
- _Enterococcus spp._
≤ 1 2 ≥ 4
- _Enterobacteriaceae_
≤ 1 2 ≥ 4
- _Pseudomonas aeruginosa_ and others not _Enterobacteriaceae_ ≤ 1 2
≥ 4
Bacterial resistance to enrofloxacin normally occurs because of the
alteration of the DNA
gyrase (topoisomerase II) by means of a mutation in the Gyr-A subunit
and with lesser
frequency, but to an important degree for Gram-positive bacteria, by
the alteration of
topoisomerase IV due to a mutation in the ParC subunit.
Other res