Biaxsig

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

Roxithromycin

থেকে পাওয়া:

Sanofi-Aventis Australia Pty Ltd

শ্রেণী:

Medicine Registered

তথ্য লিফলেট

BIAXSIG
®

(BI-AX-SIG)
_Roxithromycin (rocks-e-throw-my-sin)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Biaxsig. It does not
contain all the available information.
It does not take the place of talking to
your doctor and pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will 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 BIAXSIG IS USED
FOR
Biaxsig is used to treat infections in
different parts of the body caused by
bacteria. For example:
•
acute pharyngitis (sore throat and
discomfort when swallowing)
•
tonsillitis
•
sinusitis
•
acute bronchitis (infection of the
bronchi causing coughing)
•
exacerbation of chronic bronchitis
•
pneumonia (lung infection
characterised by fever, malaise,
headache)
•
skin and soft tissue infections
•
non gonococcal urethritis
•
impetigo (bacterial infection
causing sores on the skin)
Biaxsig is an antibiotic that belongs
to a group of medicines called
macrolides.
These antibiotics work by killing or
stopping the growth of the bacteria
that are causing your infection.
Biaxsig, like other antibiotics, does
not work against viral infections such
as the flu.
YOUR DOCTOR MAY HAVE PRESCRIBED
BIAXSIG FOR ANOTHER REASON. ASK
YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE BIAXSIG IF YOU HAVE
SEVERE LIVER PROBLEMS.
DO NOT TAKE BIAXSIG IF YOU HAVE AN
ALLERGY TO:
•
roxithromycin or any other
macrolide antibiotic eg
azithromycin, clarithromycin or
erythromycin.
•
any of the ingredients listed at the
end of this leaflet (see Product
Description)
 Symptoms of an allergic reaction
may include skin r

পণ্য বৈশিষ্ট্য

Biaxsig PI 
CCDSv5 PIv7 8 Apr 13
_ _
_Page 1  _

PRODUCT INFORMATION 
BIAXSIG
® 

NAME OF THE MEDICINE 
Biaxsig Tablets 
NON-PROPRIETARY NAME 
Roxithromycin 
CHEMICAL STRUCTURE 
Roxithromycin has the following structural formula: 
The empirical formula for roxithromycin is C
41
H
76
N
2
O
15
. Its molecular weight is 837.07. 
CAS NUMBER 
Chemical Abstracts Number: [80214-83-1] 
DESCRIPTION 
Roxithromycin is an acid-stable semi-synthetic macrolide antibiotic. It is a white crystalline powder. 
Roxithromycin  is  very  slightly  soluble  in  water,  freely  soluble  in  acetone,  in  alcohol  and  in 
methylene chloride. It is slightly soluble in
dilute hydrochloric acid. 
Biaxsig tablets contain 150mg or 300mg of roxithromycin. 
Biaxsig  tablets  also  contain  hydroxypropylcellulose,  poloxamer,  povidone,  colloidal  anhydrous 
silica,  magnesium  stearate  (470),  purified  talc  (553),  maize  starch,  hypromellose,  anhydrous 
glucose, titanium dioxide (171) and propylene glycol (1520). 
PHARMACOLOGY 
PHARMACOKINETICS 
Absorption 
Roxithromycin  is  absorbed  after  oral  administration  with  an  absolute  bioavailability  of 
approximately  50%.  Peak  plasma  concentrations  are  achieved  in  children  and  young  and  elderly 
adult patients approximately one to two hours after administration. 
As food intake delays absorption, Biaxsig should be administered at least 15 minutes before food 
or, alternatively, on an empty stomach (_i.e._ more than 3
hours after a meal). 
Absorption is not linear; with increasing doses in the range 150 mg to 300 mg, peak plasma levels 
and area under the curve (AUC) do not increase in proportion
to the dose. 
Biaxsig PI 
CCDSv5 PIv7 8 Apr 13
_ _
_Page 2  _

After  repeated  administration  of  2.5  mg/kg  every  12 �