Eybelis ophthalmic solution 0.002%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

omidenepag isopropyl

Boleh didapati daripada:

SANTEN PHARMA MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

omidenepag isopropyl

Unit dalam pakej:

1 x 2.5 ml

Dikeluarkan oleh:

Santen Pharmaceutical Co., Ltd., Shiga Plant

Risalah maklumat

EYBELIS
® OPHTHALMIC SOLUTION 0.002%
Omidenepag Isopropyl (20 micrograms/mL)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What EYBELIS is used for
2.
How EYBELIS works
3.
Before you use EYBELIS
4.
How to use EYBELIS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of EYBELIS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT EYBELIS IS USED FOR
Eybelis comes in the form of eye drops
and
belongs
to
a
group
of
medicines
called anti-glaucoma/ocular hypertension
drugs.
Eybelis
is
used
in
patients
(20
years of age and older) with open angle
glaucoma and ocular hypertension.
HOW EYBELIS WORKS
This medicine reduces the pressure in the
eye
by
promoting
the
fluid
drainage
which controls the eye’s fluid pressure.
BEFORE YOU USE EYBELIS
-
_When you must not use it _
•
If
you
are
hypersensitive
to
ingredients
contained
in
Eybelis.
_ _
•
If you are now using Tafluprost
(Tafluprost
eye
drops
or
any
products containing Tafluprost).
_ _
•
If
you
have
aphakic
eyes
(missing of lens in one or in
both
of
your
eyes)
or
have
artificial lens implanted in the
eyes.
_ _
•
The
safety
and
efficacy
of
omidenepag
isopropyl
in
children
and
adolescents
have
not
yet
been
established.
No
data are available.
_ _
-
_Before you start use it _
Before using this medicine, be sure to
tell your doctor or pharmacist:
•
If
you
have
an
ocular
inflammatory
disease
such
as
iritis or uveitis.
•
If
you
are
pregnant
or
may
possible be pregnant.
•
If you are breastfeeding.
-
_Taking other medicines _
You cannot concomitantly use Eybelis
with a certain type of medicine such as
Tafluprost (Tafluprost eye drops or any
product containing Tafluprost).
Concomitant use of Eybelis with other
glaucoma/
ocular
hypertension
medications should be done with caution.
Some medicines need special attention
when
concomitantly
used.
Be
sure
to
consult your doctor or pharmacist if you
are using other eye drops or intend to use
new medicine(s).
HOW TO USE EYBELIS
-
_Ho

Ciri produk

参天製薬　754857　エイベリス点眼液（マレーシア）添付文書
MU-2295-05〈02〉ｵﾓﾃ（22/06/06）
420×120　1° コン　　大光印刷株式会社
1. Product Description
Eybelis Ophthalmic Solution 0.002% is a clear, colourless, sterile
aqueous ophthalmic solution.
Each mL aqueous ophthalmic solution contains 20 micrograms of
omidenepag isopropyl.
The product has pH 5.5-6.1 and osmolar ratio 0.9-1.1.
2. Indication
Open angle glaucoma and ocular hypertension
3. Recommended Dosage
Use in adults (20 years of age and older)
The recommended dose is one drop in the affected eye(s) once daily.
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should not exceed
one drop in the affected eye(s) daily.
4. Route of Administration
For ophthalmic use.
5. Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Patients with aphakic eyes or intraocular lens (IOL) inserted eyes
(see section 9 Undersirable Effect).
Concomitant use with tafluprost (see section 7 Interactions with other
Medicaments).
6. Warning and Precautions
i) Paediatric population
The safety and efficacy of omidenepag isopropyl in children and
adolescents have not yet been established.
No data are available.
ii) Precautions concerning use
1. Mild, reversible ocular inflammation has been reported during
clinical trials. Eybelis should be used with
caution in patients with active ocular inflammation, including
iritis/uveitis (see section 9 Undersirable
Effect).
2. Macular edema including cystoid macular edema as well as iritis may
occur. Patients should be instructed
to immediately consult with medical professionals if they experience
abnormalities such as worsening
vision (see section 9 Undersirable Effect).
3. There is no clinical experience in patients with angle-closure
glaucoma. It is advisable to use with caution
in patients with angle-closure glaucoma.
4. Be careful not to touch the tip of the bottle to the eye directly
in order to avoid the contamination o