DUO TRAV EYE DROPS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TRAVOPROST; TIMOLOL BASE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

TRAVOPROST; TIMOLOL BASE

Unit dalam pakej:

2.5ml mL

Dikeluarkan oleh:

Alcon-Couvreur NV

Risalah maklumat

DUO TRAV EYE DROPS
Travoprost/Timolol Maleate (40μg/5mg per mL)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Duo Trav is used for
2.
How Duo Trav works
3.
Before you use Duo Trav
4.
How to use Duo Trav
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Duo Trav
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DUO TRAV IS USED FOR
Duo Trav is used to lower high pressure
inside the eye (IOP) in adult with open-
angle glaucoma or hypertension (high
pressure) in the eye who did not get
effective treatment with other medicines.
Duo Trav is prescribed if your physician
considers it appropriate for you and your
condition.
HOW DUO TRAV WORKS
Duo Trav is a combination of two active
substances, travoprost and timolol.
Travoprost increases the outflow of the
liquid inside the eye and this lowers the
pressure. Timolol reduces the production
of fluid within the eye. The two
substances work together to reduce
pressure within the eye.
If you have any questions about how
Duo Trav works or why this medicine
has been prescribed for you, ask your
doctor, pharmacist, or healthcare
provider.
BEFORE YOU USE DUO TRAV
-
_When you must not use it _
Do not take Duo Trav:
•
If you are allergic (hypersensitive)
to travoprost or to timolol or any
of the other ingredients of Duo
Trav listed in Product Description.
If you think you may be allergic,
ask your doctor for advice.
•
If you have now, or have had in
the past, breathing problems such
as asthma, severe chronic
obstructive lung disease which
may cause wheeziness, difficulty
in breathing and/or long-standing
cough.
•
If you have a slow heartbeat, heart
failure, or a heart rhythm disorder
(irregular heartbeats).
If you have any of these conditions, do
not take Duo Trav and tell your doctor.
_ _
_ _
_Pregnancy, breast-feeding _
Do not use Duo Trav if you are pregnant
unless your doctor considers it necessary.
Duo Trav may get into your breast milk.
If you are breast-feeding, ask

Ciri produk

Novartis
Malaysia Package Insert
28-May-2020, corr 26-Jun-2020
DuoTrav

1
TRADENAMES
DuoTrav

(Travoprost 40 micrograms/mL/Timolol 5 mg/mL) Eye Drops, Solution
2
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Eye drops, solution.
ACTIVE SUBSTANCE(S)
One mL of solution contains 40 micrograms of travoprost and 5 mg of
timolol (6.8 mg timolol
maleate).
EXCIPIENTS
Boric acid, mannitol, polyoxyethylene hydrogenated castor oil 40
(HCO-40), polyquaternium-1
(POLYQUAD), propylene glycol, sodium chloride, sodium hydroxide and/
or hydrochloric acid (for
pH adjustment), and purified water.
3
INDICATIONS
Decrease of intraocular pressure (IOP) in adult patients with
open-angle glaucoma or ocular
hypertension who are insufficiently responsive to topical
beta-blockers or prostaglandin analogues.
4
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
GENERAL TARGET POPULATION
ADULTS
The recommended dosage of DuoTrav is one drop in the conjunctival sac
of the affected eye(s) once
daily in the morning or evening. It should be administered at the same
time each day. The dosage of
DuoTrav should not exceed one drop in the affected eye(s) once daily
since it has been shown that
more frequent administration of prostaglandin analogues may decrease
the IOP-lowering effect.
If a dose is missed, treatment should continue with the next dose as
planned. If more than one topical
ophthalmic drug is being used, the drugs should be administered at
least 5 minutes apart.
When substituting another ophthalmic antiglaucoma medicinal product
with DuoTrav Eye Drops,
Solution, the other medicinal product should be discontinued and
DuoTrav Eye Drops, Solution
should be started the following day.
Novartis
Malaysia Package Insert
28-May-2020, corr 26-Jun-2020
DuoTrav

SPECIAL POPULATIONS
HEPATIC AND RENAL IMPAIRMENT
No studies have been conducted with DuoTrav or with timolol 5 mg/mL
eye drops in patients with
renal or hepatic impairment.
Travoprost alone has been studied in patients with mild to severe
hepatic impairment and in patients
with mil