TAFLOTAN-S ophthalmic solution 0.0015% (single-dose container)

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

Tafluprost

Dostopno od:

SANTEN PHARMA MALAYSIA SDN. BHD.

INN (mednarodno ime):

Tafluprost

Enote v paketu:

0.3mL x 30units ml

Izdeluje:

Santen Pharmaceutical Co., Ltd. Noto Plant

Navodilo za uporabo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
®
TAFLOTAN -S OPHTHALMIC SOLUTION 0.0015% (SINGLE-DOSE CONTAINER)
Tafluprost (0.0015%)
WHAT IS IN THIS LEAFLET
1.
What Taflotan-S is used for
2.
How Taflotan-S works
3.
Before you use Taflotan-S
4.
How to use Taflotan-S
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Taflotan-S
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TAFLOTAN-S IS USED FOR
It is usually used to treat primary open-
angle glaucoma or ocular hypertension.
(a buildup of fluid inside the eye).
HOW TAFLOTAN-S WORKS
This medicine promotes aqueous humour
(intraocular
fluid)
outflow
in
order
to
lower pressure in the eye.
BEFORE YOU USE TAFLOTAN-S
-
_When you must not use it _
Be sure to tell your doctor and
pharmacist,
•
If you have previously experienced
any allergic reactions (itch, rash,
etc.) to any medicines.
•
If
you
have
history
of
hypersensitivity to any of the
ingredients of this product.
-
_Before you start use it _
Be sure to tell your doctor and
pharmacist,
•
If
you
are
patient
with
aphakic/pseudophakic
eyes
(absence of the lens of the eye due
to
surgical
removal),
bronchial
asthma/history of bronchial asthma,
or intraocular inflammation (iritis,
uveitis).
•
If you are pregnant or breastfeeding.
-
_Taking other medicines _
Be
sure
to
tell
your
doctor
and
pharmacist,
•
If you are taking any other
medicinal products. (Some
medicines may interact to enhance
or diminish medicinal effects.
Beware
of
over-the-counter
medicines and dietary supplements
as
well
as
other
prescription
medicines.)
HOW TO USE TAFLOTAN-S
Before
applying,
wash
your
hands
thoroughly with soap and running water.
Next, twist and remove the tip of the
containerand discard 1 to 2 drops. Then,
pull down your lower eyelid so that the
dropper
tip
does
not
touch
eye
or
eyelashes and apply the medicine. After
applying, keep your eyes closed for 1 to 5
minutes pressing the inner corner of the
eye lightly. Wipe off any excess liquid
with a wet gauze

Lastnosti izdelka

1. Name of the Medicinal Product
1.1 Strength
Tafluprost 0.0015%
1.2 Pharmaceutical Dosage Form
Ophthalmic Solution
2. Quality and Quantitative Composition
2.1 Qualitative Declaration
_Chemical name_: 1-Methylethyl (5_Z_)-7-{(1_R_, 2_R_, 3_R_,
5_S_)-2-[(1_E_)-
3,3-difluoro-4-phenoxy-1-butenyl]-3,5-dihydroxycyclopentyl}-5-
heptenoate
_Molecular Formula_: C
25
H
34
F
2
O
5
_Molecular Weight_: 452.53
Tafluprost occurs as a colorless to light yellow, viscous liquid.
It is very soluble in ethanol, diethyl ether and acetonitrile, and
practically insoluble in water.
2.2 Quantitative Declaration
Each mL contains 15μg of tafluprost.
Each container (0.3mL) contains 4.5μg of Tafluprost.
3. Pharmaceutical Form
TAFLOTAN-S ophthalmic solution is a clear, colorless, sterile
aqueous ophthalmic solution.
4. Clinical Particulars
4.1 Therapeutic Indication
Reduction of intraocular pressure in patients with primary open-
angle glaucoma or ocular hypertension.
4.2 Posology and Method of Administration
Instill 1 drop in the affected eye(s) once daily.
4.3 Contraindication
1) Patients with combination with products containing
omidenepag isopropyl.
2) Patients with a history of hypersensitivity to any of the
ingredients of this product.
4.4 Special Warning and Precautions for use
4.4.1 Careful administration (This product should be
administered with care to the following patients.)
1) Patients with aphakia or pseudophakia [This product
may induce macular oedema including cystoid macular
oedema, and the associated visual acuity reduced.]
2) Patients with bronchial asthma or a history of bronchial
asthma [this product may aggravate or induce
asthmatic attack.]
3) Patients with endophthalmitis (iritis, uveitis) [other drugs
in this category have been reported to cause elevation
of intraocular pressure.]
4) Pregnant, parturient and lactating women [see “4.6
Pregnancy and Lactation”.]
4.4.2 Important precautions
1) Pigmentation in iris and eyelid (increased melanin
content), or hypertrichosis around the eyes may
occur. These symptoms g