Ziromin 200 mg5 mL Powder for Oral Suspension

Riik: Malaisia

keel: inglise

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

Toimeaine:

AZITHROMYCIN DIHYDRATE

Saadav alates:

MEDISPEC (M) SDN.BHD

INN (Rahvusvaheline Nimetus):

AZITHROMYCIN DIHYDRATE

Ühikuid pakis:

1 x 30 ml

Valmistatud:

World Medicine Ilac San. ve Tic. A.S

Infovoldik

ZIROMIN 200MG/5ML POWDER FOR ORAL SUSPENSION
Azithromycin 200 mg/5 ml
as Azithromycin Dihydrate
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Ziromin _
is used for
2.
How
_Ziromin_
works
3.
Before you use
_Ziromin_
4.
How to use
_Ziromin_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Ziromin_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT _ZIROMIN _IS USED FOR
This
medicine
contains
_azithromycin_
,
which is one of a group of antibiotics
called
macrolides.
It
is
used
to
treat
infections caused by certain bacteria and
other micro-organisms which include:
• Chest, throat or nasal infections (such
as bronchitis, pneumonia, tonsillitis, sore
throat (pharyngitis) and sinusitis)
• Ear infections
• Skin and soft tissue infections (such as
an abscess or boil)
•
Sexually-transmitted
diseases
caused
by
organisms
called
_Chlamydia _
_trachomatis_
or
_Neisseria gonorrhea_
. It is
also
indicated
in
the
treatment
of
chancroid due to
_Haemophilus Ducreyi_
.
HOW _ZIROMIN_ WORKS
Ziromin is an antibiotic, which belongs
to a group of medicines called azalides.
The azalides are a sub-class of a group of
antibiotics called macrolides. It works by
killing or stopping the growth of bacteria
causing
your
infection.
BEFORE YOU USE _ZIROMIN_
-
_When you must not use it _
•
If
you/your
child
are
allergic
to
_azithromycin_
,
_erythromycin_
, or any
macrolide or ketolide antibiotic, or
to
any
of
the
ingredients
of
this
medicine.
•
If you have rare hereditary fructose
intolerance,
glucose-galactose
malabsorption or sucrase-isomaltase
insufficiency problems
_Pregnancy and lactation _
_ _
Do not take
_Ziromin_
if you are pregnant
or
breast-feeding,
are
planning
to
pregnant or think you may be pregnant.
Get
advice
from
your
doctor
or
pharmacist before taking any medicine.
-
_Before you start to use it _
Talk to your doctor or pharmacist
before taking
_Ziromin_
if you/your child
have or have had any of the

Toote omadused

NAME OF THE MEDICINAL PRODUCT
Ziromin 200 mg/5 mL Powder for Oral Suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
In Each 5 ml: Azithromycin dihydrate
209.6 mg (equivalent to 200.00 mg azithromycin)
PRODUCT DESCRIPTION
Powder: White colored, cherry scented, homogeneous powder free from
particles.
Suspension: White or off-white homogeneous suspension.
_ _
PHARMACODYNAMICS
Azithromycin is a macrolide antibiotic belonging to the azalide group.
The molecule is constructed by
adding a nitrogen atom to the lactone ring of erythromycin A. The
mechanism of action of
azithromycin is based upon the suppression of bacterial protein
synthesis by means of binding to the
ribosomal 50S sub-unit and inhibition of peptide translocation.
Resistance to azithromycin may be inherent or acquired. There are
three main mechanisms of
resistance in bacteria: target site alteration, alteration in
antibiotic transport and modification of the
antibiotic.
Azithromycin demonstrates cross resistance with erythromycin resistant
gram positive isolates. A
decrease in macrolide susceptibility over time has been noted
particularly in Streptococcus
pneumoniae and Staphylococcus aureus. Similarly, decreased
susceptibility has been observed among
Streptococcus viridans and Streptococcus agalactiae (Group B)
streptococcus against other
macrolides and lincosamides.
Antibacterial spectrum of Azithromycin:
Commonly susceptible species:
Aerobic Gram-positive microorganisms: Staphylococcus aureus,
Methycillin-susceptible,
Streptococcus pneumonia, Penicillin-susceptible, Streptococcus
pyogenes (Group A).
Aerobic Gram-negative microorganisms: Haemophilus influenza,
Haemophilus parainfluenzae,
Legionella pneumophila, Moraxella catarrhalis, Neisseria gonorrhoeae,
Pasteurella multocida
Anaerobic microorganisms: Clostridium perfringens, Fusobacterium spp.,
Prevotella spp.,
Porphyromonas spp.
Other microorganisms: Chlamydia trachomatis.
Species for which acquired resistance:
Aerobic Gram-positive microorganisms: Streptococcus pneumonia,
Penici