GANFORT 0.3/5 bimatoprost 0.3 mg/mL & timolol (as maleate) 5.0 mg/mL eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

timolol maleate, Quantity: 6.8 mg/mL (Equivalent: timolol, Qty 5 mg/mL); bimatoprost, Quantity: 0.3 mg/mL

Available from:

Abbvie Pty Ltd

INN (International Name):

Bimatoprost,Timolol maleate

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: dibasic sodium phosphate heptahydrate; benzalkonium chloride; sodium hydroxide; purified water; citric acid monohydrate; hydrochloric acid; sodium chloride

Administration route:

Ophthalmic

Units in package:

1 x 3mL bottle in carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GANFORT eye drops are indicated for the reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy.

Product summary:

Visual Identification: Clear and colourless to slightly yellow solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-05-15

Patient Information leaflet

GANFORT
®
0.3/5 bimatoprost 0.3 mg per mL & timolol (as maleate) 5.0 mg per mL
Eye Drops CMIv6
1
GANFORT
®
0.3/5
EYE DROPS
(BIMATOPROST 0.3 MG PER ML AND TIMOLOL (AS MALEATE) 5.0 MG PER ML)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GANFORT
®
0.3/5
eye drops. It does not contain all
the available information. It does
not take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using GANFORT
®
0.3/5 eye drops against the benefits
they expect it will have for you.
If you have any concerns about
using this medicine, ask your doctor
or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE. YOU MAY NEED TO READ
IT AGAIN.
WHAT GANFORT
®
0.3/5 EYE DROPS
ARE USED FOR
GANFORT
®
0.3/5 eye drops are
used to lower raised pressure in the
eye and to treat glaucoma.
Glaucoma is a condition in which
the pressure of fluid in the eye may
be high. However, some people
with glaucoma may have normal
eye pressure. Glaucoma is usually
caused by a build up of the fluid
which flows through the eye. This
build up occurs because the fluid
drains out of your eye more slowly
than it is being pumped in. Since
new fluid continues to enter the
eye, joining the fluid already there,
the pressure continues to rise. This
raised pressure may damage the
back of the eye resulting in gradual
loss of sight. Damage can progress
so slowly that the person is not
aware of this gradual loss of sight.
Sometimes even normal eye
pressure is associated with damage
to the back of the eye.
There are usually no symptoms of
glaucoma. The only way of knowing
that you have glaucoma is to have
your eye pressure, optic nerve and
visual field checked by an eye
specialist or optometrist. If
glaucoma is not treated it can lead
to serious problems, including total
blindness. In fact, untreated
glaucoma is one of the most
common causes of blindness.
GANFORT
®
0.3/5 eye drops lower
the pressure in the eye by
decreasing the fluid produced

Summary of Product characteristics

GANFORT
®
PI v6 CCDS v4
1
AUSTRALIAN PRODUCT INFORMATION
GANFORT
® 0.3/5 (BIMATOPROST AND TIMOLOL (AS MALEATE))
EYE DROPS
1
NAME OF THE MEDICINE
Bimatoprost and Timolol (as maleate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bimatoprost 0.3 mg/mL and Timolol (as maleate) 5.0 mg/mL
Excipient with known effect: benzalkonium chloride (used as
preservative).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear and colourless to slightly yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GANFORT
®
0.3/5
eye drops are indicated for the reduction of intraocular pressure
(IOP) in
patients with chronic open-angle glaucoma or ocular hypertension who
are insufficiently
responsive to monotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of GANFORT
®
0.3/5
in the affected eye(s) once daily,
administered in the morning.
In order to minimise systemic absorption of GANFORT
®
0.3/5
eye drops, apply pressure to
the tear duct immediately following administration of the drug (See
_ Section 4.4 Special _
_warnings and precautions for use_
).
As with all eye drops containing benzalkonium chloride as a
preservative, there is potential
for incompatibility with other topical ophthalmic medications. If more
than one topical
ophthalmic medicinal product is to be used, other eye drops should not
be used within five to
ten minutes of using GANFORT
®
0.3/5
eye drops.
INFORMATION FOR PATIENTS - USE WITH CONTACT LENSES
The preservative in GANFORT
®
0.3/5
eye drops, benzalkonium chloride, may be absorbed
by and cause discolouration of soft contact lenses. Patients wearing
soft (hydrophilic) contact
lenses should be instructed to remove them prior to administration and
wait at least 15
minutes after instilling GANFORT
®
0.3/5
eye drops before reinserting soft contact lenses.
GANFORT
®
PI v6 CCDS v4
2
Avoid allowing the tip of the dispensing container to contact the eye
or surrounding structures
to avoid eye injury and contamina