GANFORT PF Eye Drops

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BIMATOPROST; TIMOLOL MALEATE

Boleh didapati daripada:

Allergan Malaysia Sdn Bhd

INN (Nama Antarabangsa):

BIMATOPROST; TIMOLOL MALEATE

Unit dalam pakej:

30 x 0.4 ml; 5 x 0.4ml ml

Dikeluarkan oleh:

ALLERGAN PHARMACEUTICALS IRELAND

Risalah maklumat

GANFORT
®
PF EYE DROPS
bimatoprost (0.3 mg/mL), timolol (5.0 mg/mL) Sterile Ophthalmic
Solution
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What
GANFORT
®
PF
is used for
2. How
GANFORT
®
PF
works
3. Before you use
GANFORT
®
PF
4. How to use
GANFORT
®
PF
5. While you are using it
6. Side effects
7. Storage and Disposal of
GANFORT
®
PF
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
1. WHAT GANFORT
®
PF IS USED FOR
GANFORT
®
PF
is prescribed to reduce
high pressure in the eye when other beta
blockers or prostaglandin analogues used
alone are not enough.
2. HOW GANFORT
®
PF WORKS
GANFORT
®
PF
works by reducing the
production of liquid and also increasing
the amount of liquid that is drained. This
reduces the pressure inside the eye.
3. BEFORE YOU USE GANFORT
®
PF
-
_ When you must not use it_
Do not use
GANFORT
®
PF
:
- if you are allergic (hypersensitive to
bimatoprost and timolol, or any of
the
other
ingredients
of
GANFORT
®
PF
. (for a full list of
ingredients, see section 8 “PRODUCT
DESCRIPTION”).
- if you have now or have had in the
past
respiratory
problems
such
as
asthma,
severe
chronic
obstructive
bronchitis (severe lung disease which
may cause wheeziness, difficulty
in
breathing
and/or
long
-
standing
cough).
- 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
®
PF
if
you
are
pregnant
unless
your
doctor still recommends it.
Do not use
GANFORT
®
PF
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_
GANFORT
®
PF
has only been studied
in
adults
and
therefore
its
use is not
recommended
in
children
or
adolescents.
-
_ Before yo

Ciri produk

GANFORT
®
PF eye drops (bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL) Product
Information version 2.0
NAME OF THE MEDICINE
GANFORT
®
PF Eye Drops
PRODUCT DESCRIPTION
GANFORT
®
PF is a sterile ophthalmic solution in a single-dose container.
Each mL of GANFORT
®
PF contains:
ACTIVES: Bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL
EXCIPIENTS: Sodium chloride, sodium phosphate dibasic heptahydrate,
citric acid monohydrate; and
purified water. Hydrochloric acid or sodium hydroxide may be added to
adjust pH.
_Physical Appearance: _
GANFORT
®
PF eye drops is a c
lear and colourless solution.
_Chemical structure: _
_ _
HO
HO
OH
CON
H
C
2
H
5
O
N
N
S
N
O
N
H
H
3
C
CH
3
CH
3
H
OH
HO
HO
O
O
_(structure of bimatoprost) _
_ _
_ _
_(structure of timolol maleate) _
CAS Registry No. 155206-00-1
CAS Registry No. 26921-17-5
Bimatoprost is a synthetic prostamide analogue for ophthalmic use. It
is a white to off-white powder
and is very soluble in ethyl alcohol, methyl alcohol and slightly
soluble in water.
Timolol maleate is a non-selective beta-adrenergic receptor blocking
agent. It is a white, odourless,
crystalline powder which is soluble in water, methanol and alcohol.
INDICATIONS
GANFORT
®
PF eye drops are indicated for the reduction of intraocular pressure
(IOP) in patients with
open-angle glaucoma or ocular hypertension who are insufficiently
responsive to topical beta-blockers
or prostaglandin analogues.
DOSAGE AND ADMINISTRATION
Posology
_Recommended dosage in adults (including older people) _
The recommended dose is one drop of GANFORT
®
PF in the affected eye(s) once daily, administered
either in the morning or in the evening. It should be administered at
the same time each day.
Existing literature data for GANFORT
®
(multi-dose formulation) suggest that evening dosing may be
more effective in IOP lowering than morning dosing. However,
consideration should be given to the
likelihood of compliance when considering either morning or evening
dosing.
GANFORT
®
PF
eye drops (bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL) P