PRED FORTE STERILE OPHTHALMIC SUSPENSION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PREDNISOLONE ACETATE

Boleh didapati daripada:

ABBVIE SDN BHD

INN (Nama Antarabangsa):

PREDNISOLONE ACETATE

Unit dalam pakej:

10ml mL; 5ml mL

Dikeluarkan oleh:

ALLERGAN PHARMACEUTICALS IRELAND

Risalah maklumat

PRED FORTE
® STERILE OPHTHALMIC SUSPENSION
prednisolone acetate (1% w/v)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
PRED FORTE
®
is used for
2.
How
PRED FORTE
®
works
3.
Before you use
PRED FORTE
®
4.
How to use
PRED FORTE
®
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
PRED
FORTE
®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT PRED FORTE
®
IS USED FOR
PRED
FORTE
®
is
used
for
the
treatment of eye inflammation.
HOW PRED FORTE
® WORKS
Prednisolone acetate works by limiting
inflammatory
substances
in
the
eyes,
thereby reducing redness, swelling and
irritation.
BEFORE YOU USE PRED FORTE
®
-
_When you must not use it_
_ _
_ _
Do not use
PRED FORTE
®
:
-
If you are allergic (hypersensitive to
prednisolone acetate, benzalkonium
chloride
or
any
of
the
other
ingredients of
PRED FORTE
®
. (for
a full list of ingredients, see section
“PRODUCT DESCRIPTION”).
-
If you suffer from viral, fungal or
bacterial eye infections
-
_Pregnancy and lactation _
Ask
your
doctor
or
pharmacist
for
advice
before
taking
any
medicine.
Tell your doctor if you are pregnant or
planning to become pregnant. Do not
use
PRED
FORTE
®
if
you
are
pregnant unless your doctor considers
it necessary.
Do not use
PRED FORTE
®
if you are
breast-feeding.
Ask
your
doctor
for
advice
before
taking
any
medicine
during breast-feeding.
-
_Children_
_ _
The
use
of
PRED
FORTE
®
in
children below the age of two years
has not been studied.
-
_Before you start use it _
Take
special
care
with
PRED
FORTE
®
.
If
any
of
the
following
apply, talk to your doctor before using
PRED FORTE
®
if you suffer from, or
have in the past suffered from:
-
Disease or treatment to the eye that
caused the eye surface to become
thin
-
Glaucoma or are being treated for
raised pressure within the eye or had
surgery for cataracts.
-
Herpes simplex
Tell your doctor before using
PRED
FORTE
®
, if you are:
-
Using or have used other steroid eye
drops, as frequent

Ciri produk

PRED FORTE
®
prednisolone acetate 1%
sterile ophthalmic suspension
DESCRIPTION
EACH
ML
CONTAINS:
prednisolone
acetate
10
mg
with:
benzalkonium
chloride
0.06
mg,
polysorbate 80, boric acid, sodium citrate, sodium chloride, edetate
disodium, hydroxypropyl
methylcellulose and purified water.
ACTIONS
Prednisolone acetate is a glucocorticoid that, on the basis of weight,
has 3 to 5 times the anti-
inflammatory potency of hydrocortisone. Glucocorticoids inhibit the
edema, fibrin deposition,
capillary dilatation and phagocytic migration of the acute
inflammatory response as well as
capillary proliferation, deposition of collagen and scar formation.
INDICATIONS
For steroid responsive inflammation of the palpebral and bulbar
conjunctiva, cornea and anterior
segment of the globe.
CONTRAINDICATIONS
Most viral diseases of the cornea and conjunctiva, including ,
superficial (or epithelial) herpes
simplex keratitis (dendritic keratitis), vaccinia, varicella
Mycobacterial infection of the eye fungal
diseases of ocular structures .Hypersensitivity to the active
substance or to any of the excipients
of the formulation.
WARNINGS
1.
In those diseases causing thinning of the cornea, perforation has been
reported with the use
of topical steroids. Various ocular diseases and long-term use of
topical corticosteroids have
been known to cause corneal or scleral thinning. Use of topical
corticosteroids in the presence
of thin corneal or scleral tissue may lead to perforation.
2.
Since PRED FORTE
®
contains no antimicrobial, if infection is present appropriate
measures
must be taken to counteract the organisms involved.
3.
Acute purulent infections of the eye may be masked or enhanced by the
use of topical
steroids. Prolonged use may suppress the host immune response in
ocular tissues and thus
increase the possibility of secondary ocular infections.
4.
Eye drops containing corticosteroids should not be used for more than
10 days except under
strict ophthalmic supervision with regular checks of intra-ocular
pressure (IOP).
5.
Use of intra