Axcel erythromycin ES-400 Suspension

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

ERYTHROMYCIN ETHYLSUCCINATE

Tilgængelig fra:

KOTRA PHARMA (M) SDN. BHD.

INN (International Name):

ERYTHROMYCIN ETHYLSUCCINATE

Enheder i pakken:

60 ml; 100 ml

Fremstillet af:

KOTRA PHARMA (M) SDN. BHD.

Indlægsseddel

AXCEL ERYTHROMYCIN ES-400 SUSPENSION
Erythromycin (400mg/5ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Axcel
Erythromycin
ES-
400 Suspension is used for.
2.
How
Axcel
Erythromycin
ES-
400 Suspension works.
3.
Before
you
use
Axcel
Erythromycin
ES-400
Suspension.
4.
How to use Axcel Erythromycin
ES-400 Suspension.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Erythromycin
ES-400
Suspension.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT AXCEL ERYTHROMYCIN ES-400
SUSPENSION IS USED FOR
Axcel
Erythromycin
ES-400
Suspension
is
indicated
in
the
treatment
of
infections
caused
by
susceptible organisms in the diseases
listed
below:
upper
and
lower
respiratory tract infections, pertussis
_(whooping cough)_, skin and soft tissue
infections,
otitis
media,
erythrasma
(skin disease), listeriosis, diphtheria,
primary syphilis (sexually transmitted
infection)
and
prophylaxis
of
endocarditis (infection of the heart).
HOW AXCEL ERYTHROMYCIN ES-400
SUSPENSION WORKS
Erythromycin
is
an
antibiotic
that
belongs to the
group of
medicines
called
macrolides. These
medicines
work by killing or stopping the growth
of bacteria, which cause infections.
_ _
BEFORE YOU USE AXCEL ERYTHROMYCIN
ES-400 SUSPENSION
_-When you must not use it _
Do not take Axcel Erythromycin ES-
400 Suspension if:

You have ever had an allergic
reaction to medicines containing
erythromycin
or
to
other
antibiotics
from
the
macrolide
family.
Some
of
the
symptoms
of
an
allergic
reaction
may
include
rash, itching or hives, swelling of
face, lips, tongue or other parts of
the
body,
shortness
of
breath,
wheezing
or
difficulty
in
breathing.

You are allergic to any of the
ingredients listed at the end of
this leaflet.

You have liver disease or liver
impairment.
_ _
_-Before you start to use it _
Tell your doctor if:

you are allergic to any medicines.

you have impaired liver function.

you have history of arrhythmias.

you
suf

Produktets egenskaber

ERYTHROMYCIN ES-400
COMPOSITION:
Each 5ml contains
Erythromycin Ethylsuccinate
equivalent to Erythromycin 400mg
PRESENTATION:
White to off white homogeneous suspension
with banana flavor when reconstituted.
INDICATIONS:
Indicated in the treatment of infections caused
by susceptible strains of designated organisms
in the diseases listed below: upper and lower
respiratory
tract
infections
that
caused
by
_Streptococcus _
_pyogenes_
and
_Streptococcus _
_pneumoniae_.
Pertussis
(whooping
cough)
caused by _ Bordetella pertussis_. Skin and soft
tissue
infections
caused
by
_Streptococcus _
_pyogenes_
and
_Streptococcus _
_aureus_.
Otitis
media, erythrasma, listeriosis, diphteria, primary
syphilis
in
patients
allergy
to
penicillin,
propyhlaxis of endocarditis.
PHARMACOLOGY:
_Mechanism of Action:_
Erythromycin
and
other
macrolides
bind
reversibly to the 50S subunit of the ribosome,
resulting in blockage of the transpeptidation or
translocation
reactions,
inhibition
of
protein
synthesis, and hence inhibition of cell growth.
Its action is predominantly bacteriostatic, but
high
concentrations
are
slowly
bactericidal
against the more sensitive strains. Because of
the ready penetration of macrolides into white
blood cells and macrophages there has been
some interest in their potential synergy with
host defence mechanism in vivo. Its actions are
increased at moderately alkaline pH (up to
about
8.5),
particularly
in
Gram-negative
species, probably because of the improved
cellular penetration of the nonionised form of
the drug. Erythromycin has a broad spectrum
activity. The pathogenic organisms which are
usually sensitive to Erythromycin include:
a) Gram-positive cocci: _Streptococcus _
_pneumoniae, _
_Streptococcus _
_pyogenes. _
_Staphylococcus aureus._
b) Gram-positive organisms: _Bacillus anthracis_,
_Corynebacterium diphtheriae_ etc.
c) Gram-negative cocci: _Neisseria meningitidis,_
_Neisseria gonnorrhoeae, Moraxella catarrhalis._
d) Gram-negative organisms: _ Bordetella spp., _
_Pasteurella, Haemophilus ducreyi_. Among the