Travatan 0.004% Eye Drops

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Travoprost 40 µg/mL;  

Доступно од:

Novartis New Zealand Ltd

INN (Међународно име):

Travoprost 40 µg/mL

Дозирање:

40 mcg/mL

Фармацеутски облик:

Eye drops, solution

Састав:

Active: Travoprost 40 µg/mL   Excipient: Benzalkonium chloride Boric acid Disodium edetate dihydrate Hydrochloric acid Mannitol Polyethylene glycol hydrogenated castor oil Purified water Sodium hydroxide Trometamol

Јединице у пакету:

Bottle, dropper, Sample, 2.5 mL

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Cedarburg Pharmaceuticals Inc

Терапеутске индикације:

TRAVATAN Eye Drops are indicated to decrease elevated intraocular pressure in: · ocular hypertension · open-angle glaucoma as monotherapy or as adjunctive therapy.

Резиме производа:

Package - Contents - Shelf Life: Bottle, dropper, Sample - 2.5 mL - 24 months from date of manufacture stored at or below 30°C 28 days opened stored at or below 30°C - Bottle, dropper, 2.5mL - 3 dose units - 24 months from date of manufacture stored at or below 30°C 28 days opened stored at or below 30°C

Датум одобрења:

2001-03-12

Информативни летак

TRAVATAN
®
1
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 pres

Карактеристике производа

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
TRAVATAN
TM
(travoprost) Eye Drops 0.004%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Travatan Eye Drops contains the active ingredient
travoprost 40 μg in 1 mL.
Excipient with known effect
Travatan Eye Drops are preserved with polyquaternium-1.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Travatan Eye Drops are indicated in adults to decrease elevated
intraocular pressure in
ocular hypertension and open-angle glaucoma.
Travatan Eye Drops may be used as first line monotherapy or as
adjunctive therapy.
4.2.
DOSE 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 antiglaucoma agent with Travatan
Eye Drops,
discontinue the other agent and start the following day with Travatan
Eye Drops.
4.3.
CONTRAINDICATIONS
Travatan Eye Drops are contraindicated in patients with a known
hypersensitivity to
travoprost or any of the excipients listed under 6.1. List of
excipients.
Travatan Eye Drops are also contraindicated in pregnant women or women
attempting
to become pregnant (see 4.6. Fertility, pregnancy and lactation).
4.4.
SPECIAL 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 patients
must be informed of the possibility of these changes. Unilateral
treatment can result in
permanent
heterochromia.
The
long
term
effects
on
the
melanocytes
and
any
consequences thereof are currently unknown. T