TRAVO EYE DROPS 0.004% WV

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

TRAVOPROST

متاح من:

Gopharma Sdn. Bhd.

INN (الاسم الدولي):

TRAVOPROST

الوحدات في الحزمة:

2.5ml mL

المصنعة من قبل:

Micro Labs Limited

نشرة المعلومات

TRAVO EYE DROPS 0.004% w/v
Consumer Medication Information Leaflet (RiMUP)
Travoprost 0.004% w/v Eye drops, solution
1
What is in this leaflet?
1.
What Travo Eye Drops 0.004% w/v
is used for
2.
How Travo works
3.
Before you use Travo
4.
How to use Travo
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Travo
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
What Travo Eye Drops 0.004% w/v is
used for
Travoprost
Eye
Drops
0.004%
w/v
is
used to reduce high pressure in the eye in
adults.
This
pressure
can
lead
to
an
illness called glaucoma.
How Travo works
Travo
contains
Travoprost,
one
of
a
group of medicines called prostaglandin
analogues.
It works by reducing the pressure in the
eye. It may be used on its own or with
other
drops
e.g.
beta ‑ blockers,
which
also reduce pressure.
Before you use Travo
- When you must not use it
• If you are allergic to Travoprost or any
of the other ingredients of this medicine.
Ask your doctor for advice if this applies
to you.
Pregnancy and lactation
Do not take Travo if you are pregnant,
trying to get pregnant or think you may
be pregnant.
Do
not
take
Travo
if
you
are
breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
- Before you start use it
Before you take this medicine, tell your
doctor:
 You are taking any other medicines
obtained without a prescription.
 You wear contact lenses.
- Taking other medicines
Tell your doctor or pharmacist if you are
taking or have recently taken or used any
other medicines.
How to use Travo
Always use this medicine exactly as your
doctor or the doctor treating your child
has
told
you.
You
should
check
with
your
doctor,
the
doctor
treating
your
child or pharmacist if you are not sure.
- How much to use
One drop in the affected eye or eyes,
once a day in the evening
If a drop misses the eye, try again.
- When to use it
Travo should be used once a day, in the
evening.
-
How long to use it
Only use Travoprost in both eyes if your
doctor told you

خصائص المنتج

TRAVO 0.004% W/V EYE DROPS
TRAVOPROST 0.004% W/V EYE DROPS, SOLUTION
NAME AND STRENGTH OF ACTIVE INGREDIENT:
Each ml contains:
Travoprost USP 40 micrograms …..0.004% w/v
Benzalkonium Chloride Ph. Eur ….. 0.015 % w/v
(As preservative)
Water for Injection Ph. Eur q.s to... 1 ml
PRODUCT DESCRIPTION:
Clear, colorless to pale yellow solution practically free from
particles.
PHARMACODYNAMICS:
Travoprost, a prostaglandin F
2α
PHARMACOKINETICS
analogue, is a highly selective full agonist which has a high affinity
for the prostaglandin FP receptor, and
reduces the intraocular pressure by increasing the outflow of aqueous
humour via trabecular meshwork and uveoscleral pathways. Reduction
of the intraocular pressure in man starts about 2 hours after
administration and maximum effect is reached after 12 hours.
Significant lowering
of intraocular pressure can be maintained for periods exceeding 24
hours with a single dose.
_ABSORPTION: _
Travoprost is an ester prodrug. It is absorbed through the cornea
where the isopropyl ester is hydrolyzed to the active free acid.
Studies in rabbits have shown peak concentrations of 20 ng/mL of the
free acid in aqueous humour one to two hours after topical dosing of
Travoprost. Aqueous humour concentrations declined with a half-life of
approximately 1.5 hours.
_ _
_DISTRIBUTION: _
Following topical ocular administration of Travoprost to healthy
volunteers, low systemic exposure to active free acid was
demonstrated. Peak active free acid plasma concentrations of 25 pg/mL
or less were observed between 10 and 30 minutes post-dose. Thereafter,
plasma levels declined rapidly to below the 10 pg/mL assay
quantitation limit before 1 hour post-administration. Due to the low
plasma
concentrations and rapid elimination following topical dosing, the
elimination half-life of active free acid in man could not be
determined.
_ _
_BIOTRANSFORMATION: _
Metabolism is the major route of elimination of both Travoprost and
the active free acid. The systemic metabolic pathways
parallel those of endogenous p