GANFORT

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

BIMATOPROST; TIMOLOL AS MALEATE

Tersedia dari:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

Kode ATC:

S01ED01

Bentuk farmasi:

EYE DROPS, SOLUTION

Komposisi:

BIMATOPROST 0.3 MG/ML; TIMOLOL AS MALEATE 5 MG/ML

Rute administrasi :

OCULAR

Jenis Resep:

Required

Diproduksi oleh:

ALLERGAN PHARMACEUTICALS IRELAND

Kelompok Terapi:

TIMOLOL

Area terapi:

TIMOLOL

Indikasi Terapi:

Reduction of intraocular pressure in patients with open- angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

Tanggal Otorisasi:

2015-06-30

Selebaran informasi

Page 1 of 7
GAN APL TIK JUN 23 CL
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
- 1986
This medicine is dispensed with a doctor’s prescription only
GANFORT
®
EYE DROPS
ACTIVE INGREDIENTS AND ITS CONCENTRATION:
bimatoprost 0.03% w/v and timolol (as maleate) 0.5% w/v
Inactive ingredients and allergens in this medicine: See section 2
under "Important
information about some of this medicine’s
ingredients" and section 6 "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness/for you. Do
not pass it on to
others. It may harm them, even if it seems to you that their
illness/medical condition
is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Ganfort is used to reduce pressure in the eyes of patients who have
open-angle
glaucoma or high pressure in the eye and whose response to local
treatment with
beta-blockers or prostaglandin analogues has been insufficient.
THERAPEUTIC GROUP: timolol - beta-blockers, bimatoprost - prostamides,
prostaglandin analogues.
This medicine contains two different active ingredients that both
reduce pressure in
the eye.
Bimatoprost belongs to a group of medicines called prostamides, a
prostaglandin
analogue. Timolol belongs to a group of medicines called
beta-blockers.
Your eye contains a clear, watery liquid that feeds the inside of the
eye. The liquid is
constantly being drained out of the eye and new liquid is made to
replace this. If the
liquid cannot drain out quickly enough, the pressure inside the eye
builds up and
could eventually damage your vision (an illness called glaucoma).
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.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
−
You are sensitive (aller

Karakteristik produk

GAN API MAR 23 CL
Page 1 of 12
1.
NAME OF THE MEDICINAL
PRODUCT
GANFORT
®
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
bimatoprost
0.03% w/v and timolol (as maleate) 0.5% w/v.
Excipient
with known effect
Each ml of solution contains 0.05 mg of benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Eye drops.
Colourless to slightly yellow solution.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Reduction of intraocular pressure in patients with open-angle glaucoma
or ocular
hypertension
who are insufficiently responsive to topical beta-blockers or
prostaglandin
analogues.
4.2
POSOLOGY AND METHOD OF
ADMINISTRATION
Posology
_Recommended dosage in adults (including older people_
_)_
The recommended dose is one drop of GANFORT 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 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 (see section
5.1).
If one dose is missed, treatment should continue with the next dose as
planned. The dose
should
not
exceed one drop in the affected eye(s)
daily.
_Renal and hepatic _
_impairment_
GANFORT has not been studied in patients with hepatic or renal
impairment.
Therefore
caution
should be used in treating such
patients.
_Paediatric _
_population_
GAN API MAR 23 CL
Page 2 of 12
The safety and efficacy of GANFORT in children aged 0 to 18 years has
not been
established.
No data are
available.
Method of
administration
If more than one topical ophthalmic medicinal product is to be used,
each one should
be instilled
at
least 5 minutes
apart.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic
absorption
is
reduced. This may result in a decrease in systemic side effects and an
increase in local
activity.
4.3
CONTRAINDICATIONS
▪
Hyp