LUMIGAN bimatoprost 300 micrograms/mL eye drops bottle

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

bimatoprost, Quantity: 300 microgram/mL

Inapatikana kutoka:

Abbvie Pty Ltd

Dawa fomu:

Eye Drops, solution

Tungo:

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

Njia ya uendeshaji:

Ophthalmic

Vitengo katika mfuko:

3ml, 5mL, 7.5mL

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

For the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

Bidhaa muhtasari:

Visual Identification: A clear colourless solution.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2002-09-02

Taarifa za kipeperushi

LUMIGAN
®
Bimatoprost Eye Drops-CMI Version 6.0
Page 1 of 4
LUMIGAN
® EYE DROPS
(BIMATOPROST 0.3 MG PER ML)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LUMIGAN
®
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 LUMIGAN
®
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 LUMIGAN
® EYE DROPS ARE
USED FOR
LUMIGAN
®
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.
LUMIGAN
®
eye drops
lower
the pressure in the eye by
helping the flow of fluid out
of the eye chamber.
LUMIGAN
®
eye drops
can be used alone or together
with other eyedrops/medicines
to lower ra

Tabia za bidhaa

LUMIGAN
®
PIv6-CCDSv13
1
AUSTRALIAN PRODUCT INFORMATION
LUMIGAN
® (BIMATOPROST) EYE DROPS
1
NAME OF THE MEDICINE
Bimatoprost
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LUMIGAN

eye drops contains bimatoprost 300 micrograms /mL
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
LUMIGAN
®
eye drops
is a clear, isotonic, colourless, sterile ophthalmic solution with an
osmolality of approximately 290 mOsmol/kg. It contains a preservative.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LUMIGAN

eye drops is indicated for the reduction of elevated intraocular
pressure, or open
angle glaucoma, as first line therapy or monotherapy or as adjunctive
therapy to topical beta-
blockers.
4.2
DOSE AND METHOD OF ADMINISTRATION
MONOTHERAPY:
The recommended dose is one drop of LUMIGAN

eye drops in the affected eye(s) once
daily, administered in the evening.
ADJUNCTIVE THERAPY:
The recommended dose is one drop of LUMIGAN

eye drops in the affected eye(s) once
daily, administered in the evening.
More frequent administration has not been shown to provide increased
efficacy.
If more than one topical ophthalmic medication is to be used, the
other medication should not
be used within 5 minutes of using LUMIGAN

eye drops.
LUMIGAN
®
PIv6-CCDSv13
2
In order to minimise systemic absorption of LUMIGAN

eye drops, patients should be
instructed to apply pressure to the tear duct immediately following
administration of the drug.
To avoid contamination of the solution, keep container tightly closed.
Do not touch dropper
tip to any surface. Discard contents 4 weeks after opening the bottle.
Contents are sterile if
seal is intact.
4.3
CONTRAINDICATIONS
LUMIGAN

eye drops are contraindicated in patients with hypersensitivity to
bimatoprost or
to any component of the medication.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL:
LUMIGAN

eye drops has not been studied in patients with heart block more
severe than
first degree or uncontrolled congestive