LUMIGAN 0.01% (bimatoprost ophthalmic solution)

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

BIMATOPROST

Tillgänglig från:

Allergan Malaysia Sdn Bhd

INN (International namn):

BIMATOPROST

Enheter i paketet:

3ml mL

Tillverkad av:

ALLERGAN PHARMACEUTICALS IRELAND

Bipacksedel

LUMIGAN
® 0.01%
bimatoprost (0.01%) ophthalmic solution
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
LUMIGAN
®
0.01% is used
for
2.
How
LUMIGAN
®
0.01% works
3.
Before you use
LUMIGAN
®
0.01%
4.
How to use
LUMIGAN
®
0.01%
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
LUMIGAN
®
0.01%
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
1. WHAT LUMIGAN
®
0.01% IS USED FOR
LUMIGAN
®
0.01% is used to reduce
high pressure in the eye.
2. HOW LUMIGAN
®
0.01%
WORKS
LUMIGAN
®
0.01%
increases
the
amount of fluid flowing out of the eye
which reduces the internal eye pressure.
3. BEFORE YOU USE LUMIGAN
®
0.01%
-
_When you must not use it_
_ _
_ _
Do not use
LUMIGAN
®
0.01%:
-
if you are allergic (hypersensitive to
bimatoprost,
or
any
of
the
other
ingredients of
LUMIGAN
®
0.01%.
(for
a
full
list
of
ingredients,
see
section
8
“PRODUCT
DESCRIPTION”).
-
if you have had to stop using eye
drops in the past because of a side
effect
of
the
preservative
benzalkonium chloride
-
_Pregnancy and lactation _
_ _
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.
Do
not
use
LUMIGAN
®
0.01%
if
you
are
pregnant
unless
your
doctor
still
recommends it.
LUMIGAN
®
0.01%
may
get
into
breast milk so you should not breast-
feed
while
you
are
taking
LUMIGAN
®
0.01%.
_Children: _
LUMIGAN
®
0.01%
has
not
been
tested in children under the age of 18
and
therefore
must
not
be
used
by
patients under 18 years.
-
_Before you start to use it _
Take special care with
LUMIGAN
®
0.01%. Talk to you doctor if:
-
You
have
any
eye
surgery
or
suffered trauma or infection to the
eye.
-
You have breathing problems
-
You have liver or kidney problems
-
You have dry eyes
-
You have or have had any problems
with your cornea (front transparent
part of the eye)
-
You wear contact lenses
-
You have or had low blood pressure
or low heart ra

Produktens egenskaper

LUMIGAN® 0.01%
(bimatoprost ophthalmic solution)
1 DESCRIPTION
LUMIGAN® 0.01% (bimatoprost ophthalmic solution) is a synthetic prostamide analog with
ocular hypotensive activity. Its chemical name is (Z) -7 -[(1R,2R,3R,5S) -3,5 -Dihydroxy- 2-[(1E,3S) -3 -
hydroxy- 5-phenyl -1 -pentenyl]cyclopentyl] -5 -N -ethylheptenamide, and its molecular weight is
415.58. Its molecular formula is C25H37NO4. Its chemical structure is:
Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly
soluble in water. LUMIGAN® 0.01% is a clear, isotonic, colorless, sterile o phthalmic solution with
an osmolality of approximately 290 mOsmol/kg.
LUMIGAN® 0.01% contains Active: bimatoprost 0.1 mg/mL; Preservative: benzalkonium chloride
0.2 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and purified wat er.
Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf
life ranges from 6.8 -7.8.
2 INDICATIONS AND USAGE
LUMIGAN® 0.01% (bimatoprost ophthalmic solution) is indicated for the reduction of elevated
intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as
monotherapy or as adjunctive therapy to beta -blockers) .
3 DOSAGE AND ADMINISTRATION
Dosage