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ROXITHROMYCIN-GA
_ROXITHROMYCIN FILM-COATED TABLETS_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Roxithromycin-GA.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risk of you taking
this medicine against the
benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT ROXITHROMYCIN-GA
IS USED FOR
This medicine is used to treat
various infections caused by
bacteria such as:
acute pharyngitis (sore
throat and discomfort when
swallowing)
tonsillitis
sinusitis
acute bronchitis (infection of
the bronchi causing
coughing)
pneumonia (lung infection
characterised by fever,
malaise, headache)
skin and soft tissue
infections
non gonococcal urethritis
impetigo (bacterial infection
causing sores on the skin).
It contains the active ingredient
roxithromycin. Roxithromycin
belongs to a group of
medicines called macrolides.
It works by killing or stopping
the growth of the bacteria that
are causing the infection.
However, Roxithromycin-GA
does not have any effect on
viral infections such as the flu.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN
PRESCRIBED FOR YOU. Your
doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE
ROXITHROMYCIN-GA
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NO
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제품 특성 요약
120510 Roxithromycin-GA PI v5
Page 1 of 9
PRODUCT INFORMATION
ROXITHROMYCIN-GA 150MG AND 300MG FILM-COATED TABLETS
NAME OF THE MEDICINE
Roxithromycin
_Chemical name:_ Erythromycin-[O-[(2-methoxyethoxy)-methyl]oxime]
CAS: 80214-83-1
Molecular formula_: _C
41
H
76
N
2
O
15
MW_:_ 837.1
DESCRIPTION
It is a white crystalline powder.
Roxithromycin-GA tablets also contain inactive ingredients: microcrystalline cellulose,
povidone, croscarmellose sodium, silicon dioxide, lactose, hypromellose, titanium dioxide,
magnesium stearate, macrogol 4000, poloxamer 188.
PHARMACOLOGY
Roxithromycin is a semisynthetic macrolide antibiotic.
Microbiology
At plasma concentrations achieved with the recommended therapeutic doses,
roxithromycin has been demonstrated to have _in vitro_ and clinical activity against the
following microorganisms:
_Streptococcus pneumoniae, Strep. pyogenes, Mycoplasma pneumoniae, Moraxella _
_catarrhalis, Ureaplasma urealyticum_ and Chlamydia sp.
Roxithromycin has been demonstrated to have clinical activity against the following
microorganisms which are
partially sensitive _in vitro_ to roxithromycin:
_Haemophilus influenzae_ and _Staphylococcus aureus_, except methicillin resistant _Staph. _
_aureus_ (MRSA).
120510 Roxithromycin-GA PI v5
Page 2 of 9
The following strains of microorganisms are resistant:
Multiresistant _Staph. aureus_, Enterobacteriaceae, Pseudomonas
sp. and Acinetobacter sp.
DISC SUSCEPTIBILITY TESTING
_ _
Dilution or diffusion techniques
– either quantitative (MIC) or breakpoint, should be used
following a regularly updated, recognised and standard
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