MAXIDEX OPHTHALMIC SUSPENSION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DEXAMETHASONE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DEXAMETHASONE

Unit dalam pakej:

5ml mL

Dikeluarkan oleh:

S.A. ALCON-COUVREUR N.V.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
MAXIDEX
_ _
EYE DROPS
_ _
Dexamethasone (1mg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What MAXIDEX is used for
2.
How MAXIDEX works
3.
Before you use MAXIDEX
4.
How to use MAXIDEX
5.
While you are using MAXIDEX
6.
Side effects of MAIXIDEX
7.
Storage
and
Disposal
of
MAXIDEX
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MAXIDEX IS USED FOR
Maxidex is used to treat:
•
inflammation or allergy of the eye
•
injury of the cornea caused by
chemical or heat burns
HOW MAXIDEX WORKS
Maxidex is a corticosteroid. It reduces
the
redness,
swelling
and
other
inflammatory symptoms.
BEFORE YOU USE MAXIDEX
-
_When you must not use it _
Do not use Maxidex:
•
If
you
are
allergic
to
dexamethasone or any of the other
ingredients of this medicine
•
If you have or you think you have
an eye infection including:
-
bacterial infection
-
viral infection
-
fungal infection
-
parasitic infection
-
tuberculosis of the eye
The safety and efficacy of MAXIDEX
in children and people with liver or
kidney
impairment
have
not
been
established.
_Pregnancy and breast-feeding _
If you are pregnant or breast-feeding,
you think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
using this medicine.
Maxidex is not recommended during
pregnancy or breastfeeding.
_ _
-
_Before you start to use it _
Maxidex
contains
benzalkonium
chloride. Wearing contact lenses is not
advisable during treatment of an eye
inflammation as it
may
make
your
condition
worse.
A
preservative
in
Maxidex
(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
Maxidex and wait at least 15 minutes
before putting your lenses back in.
Consult your doctor or pharmacist if
you have a disorder causing thinning
of the eye tissues before using this
medicine.
_ _
-
_Taking other medicines _
Tell y

Ciri produk

1. NAME OF THE MEDICINAL PRODUCT
MAXIDEX* ophthalmic suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains 1 mg dexamethasone.
Excipient with known effect in suspension: benzalkonium chloride 0.1
mg/ml.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, suspension.
Opaque, white to pale yellow suspension, no agglomerates.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MAXIDEX contains dexamethasone, a synthetic corticosteroid.
MAXIDEX is indicated in the management of conditions generally
responsive to corticosteroids such as:
•
Certain inflammatory eye conditions of the anterior segment: acute and
chronic anterior uveitis,
iridocyclitis, iritis and cyclitis, herpes zoster ophthalmicus.
•
Certain external
diseases such as phlyctenular kerato-conjunctivitis, non-purulent
conjunctivitis,
including vernal, allergic, catarrhal. It is very effective where
allergy is a main factor.
•
Recurrent marginal ulceration of toxic or allergic etiology.
•
Thermal and chemical burns.
•
Post-operatively to reduce inflammatory reactions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
•
Topical application (1 or 2 drops in the conjunctival sac).
•
SEVERE OR ACUTE INFLAMMATION: Every 30 to 60 minutes as initial
therapy, reducing the
dosage when favourable response is observed to every 2 to 4 hours.
Further reduction may be
made to 1 drop 3 or 4 times daily if sufficient to control
inflammation. If favourable response is not
obtained in 3 to 4 days, additional systemic or conjunctival therapy
may be indicated.
•
CHRONIC INFLAMMATION: Every 3 to 6 hours, or as frequently as
necessary. Being tapered to
discontinuation as inflammation subsides.
•
ALLERGIES OR MINOR INFLAMMATION: Every 3 to 4 hours until the desired
response is
obtained. Being tapered to discontinuation as inflammation subsides.
_ _
METHOD OF ADMINISTRATION
For ocular use.
Shake the bottle well before use.
After cap is removed, if tamper evident snap collar is loose, remove
before