ECONOPRED PLUS (PREDNISOLONE ACETATE 1%) STERILE OPHTHALMIC SUSPENSION

Country: Malaysia

Bahasa: Inggeris

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

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

Unit dalam pakej:

5ml mL

Dikeluarkan oleh:

ALCON LABS INC

Risalah maklumat

ECONOPRED PLUS EYE SUSPENSION
Prednisolone acetate (1% w/v)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Econopred Plus is used for
2.
How Econopred Plus works
3.
Before you use Econopred Plus
4.
How to use Econopred Plus
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Econopred
Plus
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ECONOPRED PLUS IS USED FOR
Econopred Plus is indicated for steroid-
responsive inflammatory conditions of
the eye.
HOW ECONOPRED PLUS WORKS
A topical corticosteroid which exerts an
anti-inflammatory action.
BEFORE YOU USE ECONOPRED PLUS
-
_When you must not use it _
_ _
Do not use
•
If you are allergic to Prednisolone or
any of the other ingredients of this
medicine.
•
If you think you have:
o
Viral, fungal or bacterial infection
of the eye
_ _
_Pregnancy and 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.
_ _
_ _
-
_Before you start to use it _
_ _
Talk to your doctor or pharmacist before
using Econopred Plus if you have
diabetes or disorder causing thinning of
the eye tissues.
-
_Taking other medicines _
Tell your doctor or pharmacist if you are
using, have recently used or might use
any other medicines.
Tell your doctor if you are using:
•
topical steroids or NSAIDs (used for
eye inflammation)
•
ritonavir or cobistat (used in HIV
treatment).
If you are using other eye drop or eye
ointment medicines, leave at least 5
minutes between each medicine. Eye
ointments should be administered last.
HOW TO USE ECONOPRED PLUS
Shake suspension well before use.
Always use this medicine exactly as your
doctor, pharmacist or nurse has told you.
Check with your doctor, pharmacist or
nurse if you are not sure.
-
_How much to use _
Two drops topically in the eye(s) four
times daily.
-
_When to use it _
_ _
Use as directed by your doctor or
pharmacist.
-

Ciri produk

1 NAME OF THE MEDICINAL PRODUCT
ECONOPRED
®
PLUS Sterile Ophthalmic Suspension, 1%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS: Each mL contains 1.0% prednisolone acetate.
PRESERVATIVE: Each mL contains 0.01% benzalkonium chloride.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, suspension
White to Off-White
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ECONOPRED
®
PLUS Sterile Ophthalmic Suspension is indicated for steroid-responsive
inflammatory conditions of the palpebral and bulbar conjunctiva,
cornea, and anterior
segment of the globe, such as allergic conjunctivitis when the
inherent hazard of steroid
use is accepted to obtain an advisable diminution in edema and
inflammation; corneal
injury from chemical radiation, or thermal burns, or penetration of
foreign bodies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
•
Two drops topically in the eye(s) four times daily.
•
In cases of bacterial infections, concomitant use of anti-infective
agents is
mandatory.
•
Care should be taken not to discontinue therapy prematurely.
•
If signs and symptoms fail to improve after 2 days, the patient should
be re-
evaluated.
•
Dosing may be reduced, but care should be taken not to discontinue
therapy
prematurely.
•
In chronic conditions, withdrawal of treatment should be carried out
by gradually
decreasing the frequency of applications.
Paediatric population
The safety and efficacy of ECONOPRED
®
PLUS Sterile Ophthalmic Suspension has not
been established.
METHOD OF ADMINISTRATION
•
For ocular use only.
•
To prevent contamination of the dropper tip and solution, care must be
taken not
to touch the eyelids, surrounding areas, or other surfaces with the
dropper tip.
•
Nasolacrimal
occlusion
or
gently
closing
the
eyelid
after
administration
is
recommended. This may reduce the systemic absorption of medicinal
products
administered via the ocular route and result in a decrease in systemic
adverse
reactions.
•
Shake suspension well prior to each use.
•
If more th