GANFORT EYE DROPS

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

BIMATOPROST; TIMOLOL MALEATE

متاح من:

ABBVIE SDN BHD

INN (الاسم الدولي):

BIMATOPROST; TIMOLOL MALEATE

الوحدات في الحزمة:

3ml mL

المصنعة من قبل:

ALLERGAN PHARMACEUTICALS IRELAND

نشرة المعلومات

GANFORT
®
EYE DROPS
Bimatoprost/timolol
(0.3mg/5.0mg per ml)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What GANFORT
®
is used for
2.
How GANFORT
®
works
3.
Before you use GANFORT
®
4.
How to use GANFORT
®
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
GANFORT
®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revision
What GANFORT
®
is used for
GANFORT
®
is prescribed to lower the
pressure
in
the
eye
of
people
with
glaucoma or high pressure in
the
eye
when other medicines like beta blockers
or
prostaglandin
analogues
used
alone
are not enough.
How GANFORT
®
works
GANFORT
®
works
by
reducing
the
production of liquid and also increasing
the amount of liquid that is drained. This
reduces the pressure inside the eye.
Before you use GANFORT
®
- When you must not use it
Do not use GANFORT
®
:
- if you are allergic (hypersensitive to
bimatoprost or timolol, or any of the
other
ingredients
of
GANFORT
®
.
(for
a
full
list
of
ingredients,
see
section
“PRODUCT
DESCRIPTION”).
- if you have now or have had in the
past
respiratory
problems
such
as
asthma,
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).
- 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
GANFORT
®
if
you
are
pregnant
unless your doctor still recommends it.
Do not use GANFORT
®
if you are
breast-feeding. Timolol may get into
your breast milk. Ask your doctor for
advice
before
taking
any
medicine
during breast-feeding.
- Children and adolescents
GANFORT
®
has only been studied in
adults
and
therefore
its
use
is
not
recommended
in
children
or
adolescents.
- Before you start to use it
Take special care with GANFORT
®
.
Always use GANFORT
®
exactly as
your doctor or pharmacist has told you.

خصائص المنتج

GANFORT® eye drops, solution
Bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL
DESCRIPTION
Each mL contains: 0.3 mg bimatoprost and 5 mg timolol equivalent to
6.8 mg of timolol
maleate, benzalkonium chloride as preservative, sodium chloride,
dibasic sodium phosphate
heptahydrate, citric acid monohydrate, hydrochloric acid or sodium
hydroxide (to adjust pH),
purified water.
CLINICAL
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
_Pharmacotherapeutic group:_
Ophthalmological – beta-blocking agents – timolol, combinations
ATC code: SO1ED 51
_Mechanism of action:_
GANFORT® consists of two active substances: bimatoprost 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. GANFORT® has a rapid onset of action.
Bimatoprost is a potent ocular hypotensive agent. It is a synthetic
prostamide, structurally
related to prostaglandin F2
α
(PGF2
α
) that acts through an identified prostamide receptor. The
mechanism of action by which bimatoprost reduces intraocular pressure
in man is by increasing
aqueous humour outflow through the trabecular meshwork and enhancing
uveoscleral outflow.
Timolol is a beta
1
and beta
2
non-selective adrenergic receptor blocking agent that does no
t
h
ave
significant intrinsic sympathomimetic, direct myocardial depressant,
or local anaesthetic
(membrane
‑
stabilising) activity. Timolol lowers IOP by reducing aqueous humour
formation.
The precise mechanism of action is not clearly established, but
inhibition of the increased cyclic
AMP synthesis caused by endogenous beta-adrenergic stimulation is
probable.
_Clinical effects:_
The IOP-lowering effect of GANFORT® is non-inferior to that achieved
by adjunctive therapy of
bimatoprost (once daily) and timolol (twice daily).
Existing literature data for GANFORT® suggest that evening dosing may
be more effective in
IOP
lowering than morning dosing. However, consideration should b