DUOTRAV travoprost 0.004% and timolol 0.5% (as maleate) eye drop solution bottle

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

travoprost, Quantity: 40 microgram/mL; timolol maleate, Quantity: 6.8 mg/mL (Equivalent: timolol, Qty 5 mg/mL)

Διαθέσιμο από:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Διεθνής Όνομα):

Timolol maleate,Travoprost

Φαρμακοτεχνική μορφή:

Eye Drops, solution

Σύνθεση:

Excipient Ingredients: ethoxylated hydrogenated castor oil; sodium hydroxide; propylene glycol; hydrochloric acid; sodium chloride; mannitol; boric acid; purified water; polyquaternium-1

Οδός χορήγησης:

Ophthalmic

Μονάδες σε πακέτο:

2.5 ml x 1

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

DuoTrav is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension for whom single agent therapy provides insufficient intraocular pressure reduction.

Περίληψη προϊόντος:

Visual Identification: Colourless to light yellow aqueous solution.; Container Type: Bottle; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2012-03-15

Φύλλο οδηγιών χρήσης

DUOTRAV
® EYE DROPS
_travoprost 0.004% and timolol 0.5%_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU START TO USE DUOTRAV EYE
DROPS.
This leaflet answers some common
questions about DuoTrav Eye Drops.
It does not contain all 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 IN AUSTRALIA FROM
WWW.NOVARTIS.COM.AU AND
WWW.MEDSAFE.GOVT.NZ IN NEW
ZEALAND.
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 risks of you using DuoTrav
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 YOUR
MEDICINE.
You may need to read it again.
WHAT DUOTRAV IS
USED FOR
DuoTrav Eye Drops are used to
lower pressure in the eye and to treat
glaucoma. Glaucoma is a condition
in which the pressure of the fluid in
the eye may be high. However, some
people with glaucoma may have
normal eye pressure. Also, some
people with raised eye pressure may
not have glaucoma.
DuoTrav Eye Drops contain two
active ingredients, travoprost and
timolol, that lower the pressure in the
eye. Travoprost belongs to a family
of medicines known as
'prostaglandins'. Timolol belongs to a
family of medicines known as 'beta-
blockers'.
DuoTrav Eye Drops lower the
pressure within the eye by two
processes. They improve the flow of
fluid from your eye(s) (travoprost)
and decrease the production of fluid
(timolol). Although DuoTrav Eye
Drops help to control your glaucoma
they do not cure it.
Before prescribing DuoTrav Eye
Drops for you, your d

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION – DUOTRAV (TRAVOPROST
AND TIMOLOL MALEATE) EYE DROPS, SOLUTION
1
NAME OF THE MEDICINE
travoprost and timolol maleate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DuoTrav Eye Drops is a combination eye drop containing a topical
prostaglandin analogue,
travoprost and a topical beta-adrenergic receptor blocking agent,
timolol maleate. Each mL of
DuoTrav Eye Drops contains 40 micrograms (0.004%) travoprost and 5 mg
(0.5%) timolol (as timolol
maleate 6.83 mg).
It is a sterile, isotonic aqueous solution with a buffered pH of
approximately 6.8 and an osmolality of
approximately 290 mOsmol/kg. The product is benzalkonium chloride
(BAK) free and uses
polyquaternium-1(POLYQUAD) as a preservative._ _
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Colourless to light yellow aqueous solution._ _
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open angle
glaucoma or ocular
hypertension for whom single agent therapy provides insufficient
intraocular pressure reduction.
4.2
D
OSE AND METHOD OF ADMINISTRATION
_RECOMMENDED DOSAGE FOR ADULTS (INCLUDING THE ELDERLY) _
Instil one drop of DuoTrav Eye Drops once daily at about the same time
each day in the conjunctival
sac of the affected eye(s).
DuoTrav Eye Drops should not be given more than once daily because
travoprost is most effective at
this dosage. If there is inadequate response to DuoTrav Eye Drops
consideration should be given to
using the individual agents with timolol dosed twice daily.
If more than one topical ophthalmic product is being used, the eye
drop products should be
administered at least five minutes apart.
2
_SWITCHING TO THERAPY WITH DUOTRAV_
_ _
_EYE DROPS _
When substituting another ophthalmic antiglaucoma agent with DuoTrav
Eye Drops, discontinue the
other agent and start the following day with DuoTrav
Eye Drops.
4.3
C
ONTRAINDICATIONS
DuoTrav Eye Drops are contraindicated in patients with a known