TRAVATAN 0.004% travoprost 40 microgram/mL eye drop solution bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

travoprost, Quantity: 40 microgram/mL

Tilgjengelig fra:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Travoprost

Legemiddelform:

Eye Drops, solution

Sammensetning:

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

Administreringsrute:

Ophthalmic

Enheter i pakken:

2.5 mL x 1, 2.5 mL x 3

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

TRAVATAN Eye Drops are indicated to decrease elevated intraocular pressure in: - ocular hypertension. - open-angle glaucoma. TRAVATAN Eye Drops may be used: - as first line monotherapy. - as adjunctive therapy.

Produkt oppsummering:

Visual Identification: Clear colourless, sterile and preserved solution; Container Type: Bottle; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2011-07-27

Informasjon til brukeren

TRAVATAN
®
_EYE DROPS 0.004%_
_travoprost_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU START TO USE TRAVATAN EYE
DROPS.
This leaflet answers some common
questions about Travatan 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 OR
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 Travatan
against the expected benefits it will
have for you.
The information in this leaflet applies
to Travatan Eye Drops only. This
information does not apply to similar
products, even if they contain the
same ingredients.
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 TRAVATAN IS
USED FOR
Travatan Eye Drops contain the
active ingredient travoprost, which
belongs to a class of medicines
known as "prostaglandins".
Travatan 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 usually caused by a
build-up of the fluid which flows
through the eye, leading to an
increase in the pressure within the
eye; some people with glaucoma
may, however, have normal pressure
within the eye.
Travatan Eye Drops lower the
pressure within the eye by increasing
the outflow of fluid from the eye.
Although Travatan Eye Drops help to
control your glaucoma, it does not
cure it.
Before prescribing Travatan

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION – TRAVATAN 0.004%
(TRAVOPROST) EYE DROPS SOLUTION
1
NAME OF THE MEDICINE
Travoprost
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
3
TRAVATAN 0.004% EYE DROPS CONTAIN 40 ΜG/ML
TRAVOPROST.PHARMACEUTICAL FORM
Eye drops, solution.
TRAVATAN Eye Drops is a clear, colourless, sterile and preserved
solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TRAVATAN Eye Drops are indicated to decrease elevated intraocular
pressure in:
•
ocular hypertension
•
open angle glaucoma
TRAVATAN Eye Drops may be used:
•
as first line monotherapy
•
as adjunctive therapy
4.2
D
OSE AND METHOD OF ADMINISTRATION
Instil one drop of TRAVATAN Eye Drops in the conjunctival sac of the
affected eye(s) each day.
Optimal effect is obtained if the dose is administered in the evening.
If more than one topical ophthalmic medicinal product is being used,
the medicines must be
administered at least 5 minutes apart.
When substituting another ophthalmic anti glaucoma agent with TRAVATAN
Eye Drops, discontinue
the other agent and start the following day with TRAVATAN Eye Drops.
INSTRUCTIONS FOR PATIENTS
In accordance with good clinical practice for the administration of
eye drops, patients should be
instructed to gently occlude the nasolacrimal ducts for two minutes
after instillation.
Discard container 4 weeks after opening.
2
4.3
C
ONTRAINDICATIONS
TRAVATAN Eye Drops are contraindicated in patients with a known
hypersensitivity to travoprost or
any of the excipients in the product (see Section 6.1 List of
Excipients).
TRAVATAN Eye Drops are also contraindicated in pregnant women or women
attempting to become
pregnant (see Section 4.6 Fertility, Pregnancy and Lactation).
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
NOT FOR INJECTION OR ORAL INGESTION
TRAVATAN Eye Drops have not been studied in patients with narrow angle
glaucoma.
EYE COLOUR CHANGES
TRAVATAN Eye Drops may gradually change the eye colour by increasing
the number of
melanosomes (pigment granules) in melanocytes. Before treatment is
instituted