TOBREX OPHTHALMIC SOLUTION 0.3%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TOBRAMYCIN

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

TOBRAMYCIN

Unit dalam pakej:

5ml mL

Dikeluarkan oleh:

S.A. ALCON-COUVREUR N.V.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
TOBREX OPHTHALMIC SOLUTION
_ _
Tobramycin (3mg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What TOBREX is used for
2.
How TOBREX works
3.
Before you use TOBREX
4.
How to use TOBREX
5.
While you are using TOBREX
6.
Side effects of TOBREX
7.
Storage and Disposal of
TOBREX
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT TOBREX IS USED FOR
Tobrex is a topical antibiotic
indicated in the treatment of bacterial
infections of the eye.
HOW TOBREX WORKS
Tobramycin works by stopping the
growth of bacteria.
BEFORE YOU USE TOBREX
_- When you must not use it _
Do not use Tobrex if you are allergic
to tobramycin or any of the other
ingredients of this medicine.
_Pregnancy and breast-feeding _
Tobrex should be used during
pregnancy only if clearly needed. If
you are pregnant, you think you may
be pregnant or are planning to have a
baby, ask your doctor or pharmacist
for advice before using this medicine.
Tobrex is not recommended during
breastfeeding.
_ _
_- Before you start to use it _
A preservative in Tobrex
(benzalkonium chloride) may cause
eye irritation and is also known to
discolour soft contact lenses.
Wearing contact lenses is not
recommended during treatment of an
eye infection. If you are allowed to
wear contact lenses you should
remove them before using this
product and wait at least 15 minutes
before putting your lenses back in.
_- Taking other medicines_
Tell your doctor or pharmacist if you
are using, have recently used or might
use any other medicines.
If you are using other antibiotic
treatment with Tobrex, ask your
doctor for advice.
_ _
Tobrex Ophthalmic Ointment may be
used
in
conjunction
with
Tobrex
Ophthalmic Solution.
HOW TO USE TOBREX
_- How much to use _
For mild and moderate infections, 1-2
drops instilled in the conjunctival sac
with regular intervals with 4 hours
between individual instillations for 7
days.
_- When to use it _
Use as directed by your doctor or
pharmacist.
_- How long to use it _
Continue using

Ciri produk

Novartis Page 2
Malaysian Package Insert 22-Mar -2019 Tobrex
®
1 NAME OF THE MEDICINAL PRODUCT
TOBREX ® (tobramycin 0.3%) Ophthalmic Solution 0.3%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active: tobramycin 0.3% (3 mg/ mL)
Preservative: benzalkonium chloride 0.01% (0.1 mg/ mL)
Excipients: See section 6.1
3 PHARMACEUTICAL FORM
Eye drops, solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
TOBREX ® Ophthalmic Solution is a topical antibiotic indicated in the treatment of external
infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of
bacterial response to topical antibiotic therapy should accompany the use of TOBREX
®
Ophthalmic Solution. Clinical studies have shown tobra mycin to be safe and effective for use in
children.
4.2 Posology and method of administration
Adults and children older than 1 year:
• For mild and moderate infections, 1 to 2 drops instilled in the conjunctival sac with regular
intervals with 4 hours between individual instillations for 7 days.