TRAVATAN 0.004% OPHTHALMIC SOLUTION

Država: Malezija

Jezik: engleski

Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivni sastojci:

TRAVOPROST

Dostupno od:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International ime):

TRAVOPROST

Jedinice u paketu:

2.5ml mL; 1.5ml mL

Proizveden od:

S.A ALCON COUVREUR N.V.

Uputa o lijeku

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
TRAVATAN EYE DROPS
_ _
Travoprost
(40 μg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What TRAVATAN is used for
2.
How TRAVATAN works
3.
Before you use TRAVATAN
4.
How to use TRAVATAN
5.
While
you
are
using
TRAVATAN
6.
Side effects OF TRAVATAN
7.
Storage
and
Disposal
of
TRAVATAN
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TRAVATAN IS USED FOR
Travatan is used to treat high pressure
in
the
eyes,
also
known
as
ocular
hypertension or open-angle glaucoma.
HOW TRAVATAN WORKS
Travatan Eye Drops belongs to a class
of
medicines
known
as
"prostaglandins".
Travatan
Eye
Drops
lower
the
pressure within the eye by increasing
the outflow of fluid from the eye.
BEFORE YOU USE TRAVATAN
-
_When you must not use it _
Do not use Travatan if you are allergic
to
travoprost
or
any
of
the
other
ingredients of Travatan.
The
efficacy
and
safety
of
TRAVATAN eye drops in children
and adolescents below the age of 18
years have not been established.
_ _
-
_Before you start to use it _
_Pregnancy and breast-feeding _
Ask
your
doctor
for
advice
before
taking any medicine.
Travatan is not recommended during
pregnancy or breastfeeding.
-
_Taking other medicines _
Please tell your doctor or pharmacist if
you are taking or have recently taken
any
other
medicines,
including
medicines
obtained
without
a
prescription.
If you have any further questions on
the use of this product, ask your doctor
or pharmacist.
HOW TO USE TRAVATAN
-
_How much to use _
One drop of Travatan in the affected
eye(s) once daily.
Always use this medicine exactly as
your doctor, pharmacist or nurse has
told
you.
Check
with
your
doctor,
pharmacist or nurse if you are not sure.
_ _
-
_When to use it _
Optimal effect is obtained if the dose
is administered in the evening.
_ _
-
_How long to use it _
Continue using Travatan for as long as
your doctor recommends.
_ _
-
_If you forget to use it _
If you forget to use Travatan, continue
with
the
next
dose
as
planned.
However, if it is almo

Svojstava lijeka

1. NAME OF THE MEDICINAL PRODUCT
TRAVATAN
40 micrograms/ml eye drops, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Travoprost 40 μg /mL, polyquaternium-1, polyoxyethylene hydrogenated
castor oil 40(HCO-40), boric acid,
mannitol, sodium chloride, propylene glycol, sodium hydroxide and/or
hydrochloric acid (to adjust pH);
purified water.
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Decrease of elevated intraocular pressure in patients with ocular
hypertension or open-angle glaucoma
(see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Use in adults including the elderly population
1 drop of TRAVATAN eye drops in the conjunctival sac of the affected
eye(s) once daily.
Optimal effect is obtained if the dose is administered in the evening.
Paediatric population
The efficacy and safety of TRAVATAN® eye drops in patients below the
age of 18 years have not been
established and its use is not recommended in these patients until
further data become available.
Hepatic and renal impairment
TRAVATAN eye drops has been studied in patients with mild to severe
hepatic impairment and in patients
with mild to severe renal impairment (creatinine clearance as low as
14 ml/min). No dosage adjustment is
necessary in these patients.
Method of Administration
TRAVATAN eye drop is for ocular use.
Nasolacrimal occlusion or gently closing the eyelid after
administration is recommended. This may reduce
the systemic absorption of medicinal products administered via the
ocular route and result in a decrease in
systemic adverse reactions.
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should not
exceed one drop in the affected eye(s) daily.
When substituting another ophthalmic anti-glaucoma agent with TRAVATAN
eye drops, the other agent
should be discontinued and TRAVATAN eye drops should be started the
following day.
If more than 1 topical ophthalmic medicinal product is being used, the
medicinal products