Zithronam Powder for Oral Suspension 200mg5ml

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

AZITHROMYCIN DIHYDRATE

Mevcut itibaren:

MEDISPEC (M) SDN.BHD

INN (International Adı):

AZITHROMYCIN DIHYDRATE

Paketteki üniteler:

50 ml; 30 ml

Tarafından üretildi:

SQUARE PHARMACEUTICALS LTD

Bilgilendirme broşürü

ZITHRONAM POWDER FOR ORAL SUSPENSION 200MG/5ML
Azithromycin 200 mg/5 ml
as Azithromycin Dihydrate USP
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Zithronam_
is used for
2.
How
_Zithronam_
works
3.
Before you use
_Zithronam_
4.
How to use
_Zithronam_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Zithronam_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT _ZITHRONAM_ 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 due to
_Chlamydia _
_trachomatis_
or
_Neisseria _
_gonorrhea_
.
It
is
also
indicated
in
the
treatment
of
chancroid
due
to
_Haemophilus ducreyi_
.
HOW _ZITHRONAM_ WORKS
Zithronam Powder for Oral Suspension
200mg/5ml
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 _ZITHRONAM_
-
_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.
This medicine contains Aspartame, not
suitable if you have phenylketonurics.
_Pregnancy and lactation _
_ _
Do
not
take
_Zithronam_
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
_Zithronam_
if you/your child have
or have had any of the follow

Ürün özellikleri

ZITHRONAM
Powder for Oral Suspension 200mg/5ml
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each 5 ml reconstituted suspension contains Azithromycin Dihydrate USP
209.62mg eq. to
Azithromycin 200mg.
PRODUCT DESCRIPTION
Before reconstitution: A white to off white free flowing granular
powder, free from any visible
foreign particles filled in HDPE bottle and sealed with SQUARE printed
white color cap.
For pack size 30ml,
After reconstitution with 20ml water, it gets a white to off-white
color suspension having flavored
sweet taste with slightly after bitter taste_._
For pack size _5_0ml,
After reconstitution with 35ml water, it gets a white to off-white
color suspension having flavored
sweet taste with slightly after bitter taste_. _
_ _
PHARMACODYNAMICS
Azithromycin is the first of a subclass of macrolides antibiotics,
known as azalides, and is chemically
different from erythromycin. Chemically it is derived by insert ion of
a nitrogen atom into the lactone
ring of erythromycin A. The mode of action of azithromycin is
inhibition of protein synthesis in
bacteria by binding to the 50s ribosomal subunit and preventing
translocation of peptides.
Azithromycin demonstrates activity in vitro against a wide range of
bacteria including:
Gram-positive Aerobic Bacteria
_Staphylococcus aureus, Streptococcus pyogenes _(group A
beta-hemolytic streptococci), _Streptococcus _
_pneumoniae, alpha-hemolytic streptococci _ (viridans group) and other
streptococci, and
_Corynebacterium _
_diphtheriae_.
Azithromycin
demonstrates
cross-resistance
with
erythromycin-
resistant Gram-positive strains, including _Streptococcus faecalis
_(enterococcus) and most strains of
methicillin- resistant staphylococci.
Gram-negative Aerobic Bacteria
_Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella
catarrhalis, Acinetobacter _species,
_Yersinia _ species, _ Legionella pneumophila_, _ Bordetella
pertussis, Bordetella parapertussis, Shigella _
_species, Pasteurella species, Vibrio cholerae _ and
_parahaemolyticus, Plesiomonas shigelloides_.
Activ