GANFORT PF 0.3/5 bimatoprost 0.3 mg/mL and timolol (as maleate) 5.0 mg/mL eye drops
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
09-08-2022
Summary of Product characteristics
(SPC)
09-08-2022
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
timolol maleate, Quantity: 6.8 mg/mL (Equivalent: timolol, Qty 5 mg/mL); bimatoprost, Quantity: 300 microgram/mL
Available from:
Abbvie Pty Ltd
INN (International Name):
Bimatoprost,Timolol maleate
Pharmaceutical form:
Eye Drops, solution
Composition:
Excipient Ingredients: dibasic sodium phosphate heptahydrate; hydrochloric acid; citric acid monohydrate; purified water; sodium chloride; sodium hydroxide
Administration route:
Topical
Units in package:
10 x 0.4 mL unit dose ampoule, 5 x 0.4 mL unit dose ampoule, 30 x 0.4 mL unit dose ampoule
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
GANFORT PF 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.
Product summary:
Visual Identification: Clear, colourless sterile ophthalmic solution.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-11-13
Patient Information leaflet
GANFORT
®
PF 0.3/5 bimatoprost 0.3 mg per mL & timolol (as maleate) 5.0 mg per
mL Eye Drops CMIv4
GANFORT
®
PF
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
®
PF
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
®
PF 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
®
PF 0.3/5 EYE
DROPS ARE USED FOR
GANFORT
®
PF 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
®
PF 0.3/5 eye drops
lower the pressure in the eye by
decreasing
Read the complete document
Summary of Product characteristics
GANFORT
®
PF PI v7 CCDS v4
1
AUSTRALIAN PRODUCT INFORMATION
GANFORT
® PF 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
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless sterile ophthalmic solution. Contains no
antimicrobial agent.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GANFORT
®
PF 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
®
PF 0.3/5 in the affected eye(s) once daily,
administered in the morning.
In order to minimise systemic absorption of GANFORT
®
PF 0.3/5 eye drops, apply pressure
to the tear duct for at least 2 minutes immediately following
administration of the drug
(SEE
PRECAUTIONS)
.
If more than one topical ophthalmic medicinal product is to be used,
each one should be
instilled at least 5 minutes apart.
The unit dose container is for single use only; one container is
sufficient to treat both eyes.
Any unused solution should be discarded immediately after use. 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.
INFORMATION FOR PATIENTS - USE WITH CONTACT LENSES:
Patients wearing soft (hydrophilic) contact lenses should be
instructed to remove them prior
to administration of GANFORT® PF 0.3/5 and wait at least 15 minutes
after instilling
GANFORT® PF 0.3/5 before reinserting soft contact lenses.
Patients should be instructed to avoid allowing the tip of the
dispensing container to contact
the eye or surrounding structures to avoid eye injury and
contamination of eye drops.
GANFORT
®
PF PI v7 CCDS v4
2
4.3
CONTRAINDICATI
Read the complete document
