LUMIGAN PF-bimatoprost 300 microgram/ mL single dose ampoule

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

bimatoprost, Quantity: 300 microgram/mL

Disponível em:

Abbvie Pty Ltd

DCI (Denominação Comum Internacional):

Bimatoprost

Forma farmacêutica:

Eye Drops, solution

Composição:

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

Via de administração:

Ophthalmic

Unidades em pacote:

30 x 0.4 mL unit dose ampoules, 5 x 0.4 mL unit dose ampoules (sample pack)

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

LUMIGAN PF 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

Resumo do produto:

Visual Identification: Clear, colourless sterile ophthalmic solution; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 9 Months; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Registered

Data de autorização:

2013-05-15

Folheto informativo - Bula

LUMIGAN
®
PF
Bimatoprost Eye Drops-CMI Version 5.0
Page 1 of 3
LUMIGAN
® PF EYE DROPS
(BIMATOPROST 300 MICROGRAM PER ML)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LUMIGAN
®
PF 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
®
PF 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
® PF EYE DROPS
ARE USED FOR
LUMIGAN
®
PF 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
®
PF eye drops lower the
pressure in the eye by helping the
flow of fluid out of the eye chamber.
LUMIGAN
®
PF eye drops can be
used alone or together with other

Características técnicas

LUMIGAN
®
PF PIv9 CCDSv13
1
AUSTRALIAN PRODUCT INFORMATION
LUMIGAN
® PF (BIMATOPROST) EYE DROPS
1
NAME OF THE MEDICINE
Bimatoprost
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LUMIGAN

PF 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
®
PF eye drops is a clear, isotonic, colourless, sterile ophthalmic
solution with an
osmolality of approximately 290 mOsmol/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LUMIGAN

PF 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

PF eye drops in the affected eye(s) once
daily, administered in the evening.
ADJUNCTIVE THERAPY:
The recommended dose is one drop of LUMIGAN

PF eye drops in the affected eye(s) once
daily, administered in the evening.
More frequent administration has not been shown to provide increased
efficacy.
LUMIGAN
®
PF PIv9 CCDSv13
2
If more than one topical ophthalmic medication is to be used, the
other medication should not
be used within 5 minutes of using LUMIGAN

PF eye drops.
In order to minimise systemic absorption of LUMIGAN

PF eye drops, patients should be
instructed to apply pressure to the tear duct immediately following
administration of the drug.
Each ampoule is intended for a single treatment in the affected
eye(s). Discard the ampoule
immediately after use. For the 30 x 0.4 mL pack once the tray is
opened, the ampoules should
be used within 30 days.
4.3
CONTRAINDICATIONS
LUMIGAN

PF eye drops are contraindicated in patients with significant
hypersensitivity to
bimatoprost or to any component of the medication.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL:
LUMIGAN
®
PF eye drops has not been studied in patients with heart block more
severe than
first degree or un