COMBIGAN EYE DROPS (Brimonidine tartrate 2mgml and timolol 5mgml opthalmic solution)

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Dostopno od:

ABBVIE SDN BHD

INN (mednarodno ime):

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Enote v paketu:

5ml mL

Izdeluje:

ALLERGAN PHARMACEUTICALS IRELAND

Navodilo za uporabo

COMBIGAN™ EYE DROPS
brimonidine tartrate/timolol (2mg/5mg per 1ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
COMBIGAN™
is used for
2.
How
COMBIGAN™
works
3.
Before you use
COMBIGAN™
4.
How to use
COMBIGAN™
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
COMBIGAN™
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT COMBIGAN™
IS USED FOR
COMBIGAN™
is prescribed to reduce
high pressure in the eye of people with
glaucoma or high pressure in
the
eye
when other medicines like beta-blocker
eye drops used alone are not enough.
HOW COMBIGAN™ WORKS
COMBIGAN™
works by reducing the
production
of
liquid
in
the
eye
and
increasing the amount of liquid that is
drained
away.
This
reduces
the
eye
pressure.
BEFORE YOU USE COMBIGAN™
-
_When you must not use it_
_ _
_ _
Do not use
COMBIGAN™
:
-
If you are allergic (hypersensitive to
brimonidine
tartrate,
timolol,
beta-
blockers,
or
any
of
the
other
ingredients of
COMBIGAN™
. (for
a full list of ingredients, see section
“PRODUCT
DESCRIPTION”).
Symptoms
of
an
allergic
reaction
may include swelling of the face,
lips and throat, wheeziness, feeling
faint, shortness of breath, itching or
redness around the eye.
-
if you have now or have had in the
past
breathing
problems
such
as
asthma or severe chronic obstructive
lung disease.
-
if you have heart problems such as
low heart rate, heart failure, heart
beat disorders (unless controlled by
a pacemaker).
-
if
you
are
taking
monoamine
oxidase (MAO) inhibitors or certain
other antidepressant medicines.
If you think any of these points apply
to
you,
do
not
use
COMBIGAN™
until you have talked again to your
doctor.
-
_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
COMBIGAN™
if you are
pregnant unless your doctor considers
it necessary.
Do not use
COMBIGAN™
if you are
breast-feedi

Lastnosti izdelka

* ARTWORK IS ACTUAL SIZE
* DROP NOTES AND TEMPLATE BEFORE PROCESSING
* IF REQUIRED, BARCODE AND CONTROL BAR(S) WILL BE ADDED BY SUPPLIER
* PERFORATION REQUIRED: NO
PART NUMBER:
92298MY_INT_02
DRAWING NUMBER:
0144701
DATE OF REVISION:
06 FEB 2018
PAGE:
1 OF 2
COMBIGAN
®
EYE DROPS
brimonidine tartrate 2 mg/mL and timolol 5 mg/mL
92298MY_INT_02
DESCRIPTION AND COMPOSITION
Each mL contains: 2.0 mg brimonidine tartrate (equivalent to 1.3 mg of
brimonidine) and
5.0 mg timolol (equivalent to 6.8 mg of timolol maleate) with
benzalkonium chloride,
sodium phosphate monobasic monohydrate, sodium phosphate dibasic
heptahydrate,
hydrochloric acid or sodium hydroxide to adjust pH, and purified
water. COMBIGAN® is a
clear, greenish-yellow to light greenish-yellow solution.
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
_Pharmacotherapeutic group:_
Ophthalmological – antiglaucoma preparations and miotics -beta
blocking agents - timolol,
combinations
ATC code: SO1ED 51
_Mechanism of action:_
COMBIGAN® consists of two active substances: brimonidine tartrate and
timolol maleate.
These two components decrease elevated intraocular pressure (IOP) by
complementary
mechanisms
of
action
and
the
combined
effect
results
in
additional
IOP
reduction
compared
to
either
compound
administered
alone.
COMBIGAN®
has
a
rapid
onset
of action.
Brimonidine tartrate is an alpha-2 adrenergic receptor agonist that is
1000-fold more
selective for the alpha-2 adrenoreceptor than the alpha-1
adrenoreceptor. This selectivity
results in no mydriasis and the absence of vasoconstriction in
microvessels associated
with human retinal xenografts.
It is thought that brimonidine tartrate lowers IOP by suppressing
aqueous humour inflow
and enhancing uveoscleral outflow. Timolol is a beta
1
and beta
2
non-selective adrenergic
receptor blocking agent that does not have significant intrinsic
sympathomimetic, direct
myocardial
depressant,
or
local
anaesthetic
(membrane-stabilising)
activity.
Timolol
lowers IOP by reducing aqueous humour formation. The precise mec