BIMTOP bimatoprost 300 microgram/mL eye drop bottle

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

bimatoprost, Quantity: 300 microgram/mL

Dostupné s:

Viatris Pty Ltd

INN (Mezinárodní Name):

Bimatoprost

Léková forma:

Eye Drops

Složení:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; dibasic sodium phosphate; benzalkonium chloride; citric acid monohydrate; water for injections; sodium chloride

Podání:

Ophthalmic

Jednotky v balení:

3, 1

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

BIMTOP 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.

Přehled produktů:

Visual Identification: Clear colorless aqueous solution; Container Type: Bottle; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizace:

Licence status A

Datum autorizace:

2017-04-18

Informace pro uživatele

BIMTOP
®
_bimatoprost_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BIMTOP 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 BIMTOP 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 BIMTOP IS USED
FOR
BIMTOP 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.
BIMTOP eye drops lower the
pressure in the eye by helping the
flow of fluid out of the eye chamber.
This medicine can be used alone or
together with other eyedrops/
medicines to lower raised pressure
within your eyes.
Although BIMTOP eye drops help
control your condition, they will not
cure it.
This medicine

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION
BIMTOP
®
_bimatoprost eye drops _
1
NAME OF THE MEDICINE
Bimatoprost
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of eye drops contains 300 micrograms of bimatoprost as
the active ingredient.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
BIMTOP is a clear, colourless aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BIMTOP 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 BIMTOP in the affected eye(s) once
daily, administered in the evening.
ADJUNCTIVE THERAPY
The recommended dose is one drop of BIMTOP 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 BIMTOP eye drops.
In order to minimise systemic absorption of BIMTOP 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
BIMTOP 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
Bimatoprost eye drops has not been studied in patients with heart
block more severe than first degree or
uncontrolled congestive heart failure. There have been a limited
number of spontaneous reports of bradycardia
or hypotension with bimatoprost eye drops. Bimatoprost eye drops
should be used with caution in patients
predisposed to low heart rate or low