IZBA 30 microgramsmL eye drops solution

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TRAVOPROST

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

TRAVOPROST

Unit dalam pakej:

2.5ml ml

Dikeluarkan oleh:

ALCON COUVREUR N.V

Risalah maklumat

IZBA
Travoprost 30 microgram/mL
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Izba
_ _
is used for
2.
How Izba
_ _
works
3.
Before you use Izba
4.
How to use Izba
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Izba
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IZBA_ _IS USED FOR
IZBA contains travoprost, one of a
group of medicines called prostaglandin
analogues.
IZBA is used to reduce high pressure in
the eye in adults. This pressure can lead
to an illness called glaucoma
HOW IZBA_ _WORKS
Izba works by decreasing intraocular
pressure in patients with open-angle
glaucoma or ocular hypertension.
BEFORE YOU USE IZBA
-
_When you must not use it _
DO NOT use IZBA if you are allergic
to Travoprost or any of the other
ingredients of this medicine.
_Pregnancy and breast-feeding _
Do not use IZBA if you are pregnant.
If you think that you may become
pregnant, speak with your doctor right
away. If you could become pregnant
you must use adequate contraception
whilst you are using IZBA.
Do not use IZBA if you are
breastfeeding. IZBA may get into your
milk.
_ _
-
_Before you start to use it _
Please ensure that you remove contact
lenses before instilling IZBA.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines including any that you
buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE IZBA
-
_How much to use _
The recommended dose is one drop in
the affected eye or eyes, once a day-in
the evening.
Only use IZBA in both eyes if your
doctor told you to. Use it for as long as
your doctor told you to.
-
_When to use it _
Use as directed by your doctor or
pharmacist.
-
_How long to use it _
Continue taking IZBA for as long as
your doctor recommends.
-
_If you forget to use it _
Consult your doctor or pharmacist on
what you should do if you forget to use
it.
-
_If you use too much (overdose) _
Contact your doctor immediately or go
to the Emergency Departme

Ciri produk

1. NAME OF THE MEDICINAL PRODUCT
IZBA 30 micrograms / ml eye drops, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 30 micrograms of travoprost.
Preservative : 1 ml of solution contains 10 micrograms of
polyquaternium-1.
Excipients
with
known
effect
:
1
ml
of
solution
contains
7.5
mg
propylene
glycol
and
2
mg
polyoxyethylene hydrogenated castor oil 40 ( HCO-40 ) ( see section
4.4 ).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to light yellow solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IZBA eye drops contains travoprost, a prostaglandin analogue.
IZBA eye drops is indicated for the decrease of elevated intraocular
pressure in adult patients with ocular
hypertension or open-angle glaucoma (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use in adults, including elderly patients
The dose is 1 drop of IZBA 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.
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should not
exceed 1 drop in the affected eye(s) daily.
When substituting another ophthalmic antiglaucoma medicinal product
with IZBA eye drops, the other
medicinal product should be discontinued and IZBA eye drops should be
started the following day.
Use in patients with hepatic or renal impairment
Travoprost 30 μg / ml has not been studied in patients with hepatic
or renal impairment. However,
travoprost 40 μg / ml 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 (see section 5.2).
Therefore, no need for dose adjustment at the lower concentration of
active ingredient is anticipated.
Use in children and adolescents
The safety and efficacy of IZBA eye drops in children and adolescents