VIZO-PF BIMATOPROST bimatoprost 300 microgram/mL eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bimatoprost, Quantity: 300 microgram/mL

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

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

Administration route:

Ophthalmic

Units in package:

1 x 3.0 ml bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Clear, colourless aqueous solution practically free from particles; Container Type: Bottle; Container Material: LDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-01-17

Patient Information leaflet

VIZO-PF BIMATOPROST EYE DROPS
(BIMATOPROST 300 MICROGRAM PER ML)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Vizo-PF Bimatoprost
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
Vizo-PF Bimatoprost 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 VIZO-PF BIMATOPROST EYE DROPS ARE USED FOR
Vizo-PF Bimatoprost 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.
Vizo-PF Bimatoprost eye drops lower the pressure in the eye by helping
the flow of fluid out of the eye chamber.
Vizo-PF Bimatoprost eye drops can be used alone or together with other
eye drops/medicines t

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
– VIZO-PF BIMATOPROST (BIMATOPROST)
1. NAME OF THE MEDICINE
Bimatoprost
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of Vizo-PF Bimatoprost contains 300 micrograms of Bimatoprost.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drop solution.
Vizo-PF Bimatoprost is a clear, isotonic, colourless, sterile
ophthalmic solution and is
practically free from visible particles.
The solution has an osmolality of approximately 290 mOsmol/kg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vizo-PF Bimatoprost 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 Vizo-PF Bimatoprost
eye drops in the
affected eye(s) once daily, administered in the evening.
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Page 1 of 15
Adjunctive Therapy: The recommended dose is one drop of Vizo-PF
Bimatoprost 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 Vizo-PF Bimatoprost eye drops.
In order to minimise systemic absorption of Vizo-PF Bimatoprost 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.
For individual patient use only.
4.3 CONTRAINDICATIONS
Vizo-PF Bimatoprost 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
Vizo-PF Bimatoprost has not been studied in patients