Azyter 15mg/g Eye Drops

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
21-05-2019
Ciri produk Ciri produk (SPC)
21-05-2019

Bahan aktif:

AZITHROMYCIN DIHYDRATE

Boleh didapati daripada:

TRB CHEMEDICA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

AZITHROMYCIN DIHYDRATE

Unit dalam pakej:

6 Units

Dikeluarkan oleh:

Unimed Laboratories

Risalah maklumat

                                AZYTER
®
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
Azithromycin dihydrate (15 mg/g)
1/2
WHAT IS IN THIS LEAFLET
1.
What AZYTER is used for
2.
How AZYTER works
3.
Before you use AZYTER
4.
How to use AZYTER
5.
While you are using AZYTER
6.
Side effects
7.
Storage and Disposal of AZYTER
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial number
WHAT AZYTER IS USED FOR
AZYTER (eye drops)
is
used for
the
local treatment of certain eye infections
of
bacterial
origin in adults (including
the elderly) and in children from birth
to 17 years of age:

purulent bacterial conjunctivitis,

trachomatous conjunctivitis
(particular ocular infection due to
bacteria called
_Chlamydia_
_trachomatis_
, found or occurring in
some countries).
HOW AZYTER WORKS
AZYTER contains
azithromycin,
an
antibiotic
belonging to the
macrolide
class.
BEFORE YOU USE AZYTER
_When you must not use it_
Do not use AZYTER if you are allergic
to azithromycin,
to any other antibiotic
from
the
macrolide
class
or
to
triglycerides, medium-chain.
_Before you start to use it_
Talk
to
your
doctor,
or
the
doctor
treating your
child or
your
pharmacist
or nurse before using AZYTER.
This
medicine
is
only
intended
for
ocular use.
Do not inject or swallow it.
_Pregnancy:_
AZYTER can
be
used
during
pregnancy.
Your
doctor
may
prescribe this medicine for
you while
you are pregnant,
if he/she considers it
to be necessary.
_Breast_
_feeding:_
Limited data indicate
that
azithromycin is excreted in breast
milk,
this medicine can be used during
breast feeding.
If
you are pregnant
or
breast
feeding,
think
you
may
be
pregnant
or
are
planning
to
have
a
baby,
ask
your
doctor or pharmacist
for advice before
taking this medicine.
_Taking other medicines_
If you are using any other eye medicine
to be applied in the eye, you should:

apply the other ophthalmic
medicine,

wait for 15 minutes,

apply AZYTER last.
Tell
your doctor or the doctor treating
your
child or
pharmacist
if
you are
using or
have recently use
                                
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                                This printing proof represents exactly the way the PI will be printed.
This means that by puting your signature on it, you fully accept its 
design, texts and that anything comply on a regulatory point of view  to your local requirements.
Name:
Date:
Signature: Your signature on this pdf means that you guarantee that technicals 
aspects of this PI comply with the size of the PI, the cutting shapes,  the margins, the codes and their positions, the reserved areas, the 
varnished areas, the braille and all the embossed elements and all 
the necessary marks in order to ensure that the fi nished product will  look at what is shown below.
You should not modify this pdf.
Name:
Date:
Signature:
!! Customer approval !!
!! Manufacturer approval !!
Product: REG Safety AZYTER 6 UD Malaisie MAY-MSA - 1225U6MYS-2 - (ENG) PI Théa’s Code: N1225U6MYS-2/0119
Manufacturer: UNIMED PI Manufacturer’s Code: XXAZYXXX
Type of PI: LEAFLET Dimensions (WH): 300 x 295 mm
Remarks: Théa’s Template: GAB-UNED-N-300x295-0812-2
Fonts: Amœbia, Formata Title size: 18 pt
Subtitle size: 12 pt Text size: 9 pt Interline size: 5 pt
Code size: 7 pt Soft: InDesign (CC)
Global version: 0119-5 Global version date: 2019-05-13
Customer version: 5 Customer version date: 2019-05-13
Technical version: 0 Technical version date: 2019-01-11	Black
Black 67 %
Black 35 %
Used colours
3 PAGES
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