TOBRADEX EYE OINTMENT

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DEXAMETHASONE; TOBRAMYCIN

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DEXAMETHASONE; TOBRAMYCIN

Unit dalam pakej:

3.5gm mcg/mL

Dikeluarkan oleh:

S.A. ALCON-COUVREUR N.V.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
TOBRADEX OPHTHALMIC
SUSPENSION/OINTMENT
_ _
Tobramycin/ Dexamethasone (3mg/ml / 1mg/ml or 3mg/g / 1mg/g)
1
WHAT IS IN THIS LEAFLET
1.
What TOBRADEX is used for
2.
How TOBRADEX works
3.
Before you use TOBRADEX
4.
How to use TOBRADEX
5.
While
you
are
using
TOBRADEX
6.
Side effects of TOBRADEX
7.
Storage
and
Disposal
of
TOBRADEX
8.
Product Description
9.
Manufacture
and
Product
Registration Holder
10.
Date of revision
WHAT TOBRADEX IS USED FOR
Tobradex
is
used
to
treat
eye
inflammation which is responsive to
steroid and to treat or prevent bacterial
infection of the eye.
HOW TOBRADEX WORKS
Tobradex exerts an anti-inflammatory
and anti-bacterial action.
BEFORE YOU USE TOBRADEX
-
_When you must not use it _
If you are allergic to dexamethasone,
tobramycin
or
any
of
the
other
ingredients of this medicine.
_ _
If you think you have:
•
Herpes
simplex
keratitis,
Smallpox,
Chickenpox/Herpes
Zoster, or any other viral infection
of the eye
•
Tuberculosis of the eye
•
Fungal diseases of the eye or an
untreated parasitic eye infections
_ _
_ _
_ _
_Pregnancy and breast-feeding _
If
you
are
pregnant
or
might
get
pregnant, or if you are breast-feeding,
talk to your doctor before you use this
medicine.
Tobradex is not recommended during
pregnancy or breastfeeding.
_ _
-
_Before you start to use it _
Tobradex
contains
benzalkonium
chloride. Wearing contact lenses (hard
or
soft)
is
not
advisable
during
treatment of eye inflammation as it
may make your condition worse.
A
preservative
in
Tobradex
(benzalkonium chloride) may cause
eye irritation and is also known to
discolor soft contact lenses. If your
healthcare provider considers that you
can use contact lenses, you should
remove them before using Tobradex
and wait 15 minutes before putting
your lenses back in.
_[Only applicable _
_for _
_Ophthalmic _
_Suspension _
_(Eye _
_Drops)] _
_ _
-
_Taking other medicines _
Tell your doctor or pharmacist if you
are using, have recently used or might
use any other medicines.
Especia

Ciri produk

Novartis
Page 2
Malaysian Package Insert
22-Mar-2019
Tobradex
®
1
NAME OF THE MEDICINAL PRODUCT
Tobradex (Tobramycin and Dexamethasone) Sterile Ophthalmic Suspension
Tobradex (Tobramycin and Dexamethasone) Sterile Ophthalmic Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
[TOBRADEX STERILE OPHTHALMIC SUSPENSION]
Active: 1 mL of suspension contains 3 mg of tobramycin and 1 mg of
dexamethasone
Preservative: benzalkonium chloride (0.01%)
Excipients: See section 6.1
[TOBRADEX STERILE OPHTHALMIC OINTMENT]
Active: 1 gram ointment contains 3 mg of tobramycin and 1 mg of
dexamethasone
Preservative: chlorobutanol, anhydrous (0.5%)
Excipients: See section 6.1
3
PHARMACEUTICAL FORM
Ophthalmic Suspension: white to off-white suspension
Ophthalmic Ointment: white to off-white homogeneous ointment
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tobradex Ophthalmic Suspension and Ointment are indicated for
steroid-responsive inflammatory
ocular conditions for which a corticosteroid is indicated and where
superficial bacterial ocular
infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the
palpebral and bulbar conjunctiva,
cornea and anterior segment of the globe where the inherent risk of
steroid use in certain infective
Novartis
Page 3
Malaysian Package Insert
22-Mar-2019
Tobradex
®
conjunctivitides is accepted to obtain a diminution in edema and
inflammation. They are also
indicated in chronic anterior uveitis and corneal injury from
chemical, radiation or thermal burns, or
penetration of foreign bodies.
The use of a combination drug with an anti-infective component is
indicated where the risk of
superficial ocular infection is high or where there is an expectation
that potentially dangerous
numbers of bacteria will be present in the eye. The particular
anti-infective drug in this product is
active against the following common bacterial eye pathogens:
Staphylococci, including
_S. aureus_
and
_S. epidermidis_
(coagulase-positive and coagulase-negative), i