BRINZOQUIN 1.0% brinzolamide 10mg/mL eye drops

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

brinzolamide, Quantity: 10 mg/mL

Tillgänglig från:

Novartis Pharmaceuticals Australia Pty Ltd

Läkemedelsform:

Eye Drops

Sammansättning:

Excipient Ingredients: benzalkonium chloride; disodium edetate; sodium chloride; tyloxapol; mannitol; carbomer 974P; hydrochloric acid; sodium hydroxide; purified water

Administreringssätt:

Ophthalmic

Enheter i paketet:

10mL, 5mL

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

BrinzoQuin Eye Drops 1.0% are indicated to decrease intraocular pressue in: ocular hypertension & open-angle glaucoma.

Produktsammanfattning:

Visual Identification: White to off-white, uniform suspension.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Licence status A

Tillstånd datum:

2004-05-20

Bipacksedel

BRINZOQUIN
® EYE DROPS
1.0%
_Brinzolamide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU USE ANY BRINZOQUIN
EYE DROPS.
This leaflet answers some common
questions about BrinzoQuin. It does
not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you taking
Brinzoquin against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BRINZOQUIN IS
USED FOR
BrinzoQuin Eye Drops contain the
active ingredient brinzolamide,
which belongs to a class of medicines
known as "carbonic anhydrase
inhibitors".
BrinzoQuin Eye Drops are used,
either alone or in combination with
other eye drops/medicines, 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 the
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 los

Produktens egenskaper

1
AUSTRALIAN PRODUCT INFORMATION – BRINZOQUIN 1.0%
(BRINZOLAMIDE) EYE DROPS
1
NAME OF THE MEDICINE
brinzolamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BrinzoQuin 1.0% Eye Drops contain brinzolamide 10 mg/mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops
BrinzoQuin 1.0% Eye Drops is a sterile, preserved white to off-white,
uniform suspension.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
BrinzoQuin Eye Drops 1.0% are indicated to decrease intraocular
pressure in:
•
ocular hypertension
•
open-angle glaucoma
4.2
D
OSE AND METHOD OF ADMINISTRATION
Instil one drop of BrinzoQuin Eye Drops 1.0% in the conjunctival sac
of the affected eye(s) twice
daily.
When substituting BrinzoQuin Eye Drops 1.0% for another ophthalmic
anti-glaucoma agent,
discontinue the other agent after a full day of correct dosing;
BrinzoQuin Eye Drops 1.0% should be
used on the next day.
CONCOMITANT THERAPY
BrinzoQuin 1.0% Eye Drops have been used concomitantly with other
agents e.g. travoprost,
latanoprost, timolol (see Section 5.1 Parmacodynamic Properties –
Clinical Trials). In case of
concomitant therapy with other agents, the eye drops should be
administered with an interval of at
least five minutes.
Patients should be advised:
•
BrinzoQuin Eye Drops 1.0% should be shaken well prior to use;
•
that instillation of eye drops may cause initial discomfort (see
Section 4.8 Adverse effects
(Undesirable effects));
2
•
to apply pressure to the tear duct for two minutes immediately after
administration in order
to minimise systemic absorption; and
•
Discard container 4 weeks after opening.
4.3
C
ONTRAINDICATIONS
BrinzoQuin Eye Drops 1.0% are contraindicated in patients with a known
hypersensitivity to
brinzolamide, sulfonamides or any of the excipients in the product
(see Section 6.1 List of
excipients).
BrinzoQuin Eye Drops 1.0% are also contraindicated in patients with
severe renal impairment and in
patients with hyperchloraemic acidosis.
4.4
S
PECIAL WARNINGS AND PRECAU