ZOLAMIDOL (Dorzolamide 2% + Timolol 0.5% Eye Drops)

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

DORZOLAMIDE HCL; TIMOLOL MALEATE

Beszerezhető a:

ARMS PHARMA SDN. BHD.

INN (nemzetközi neve):

DORZOLAMIDE HCL; TIMOLOL MALEATE

db csomag:

5 ml; 10 ml

Gyártó:

INDOCO REMEDIES LIMITED

Betegtájékoztató

_Consumer Medication Information Leaflet (RiMUP)_
ZOLAMIDOL (DORZOLAMIDE 2% + TIMOLOL 0.5%
EYE DROPS)
Dorzolamide 2% and Timolol 0.5%
1
WHAT IS IN THIS LEAFLET.
1.
What
ZOLAMIDOL
(DORZOLAMIDE
2% + TIMOLOL 0.5% EYE DROPS)
is
used for
2.
How
ZOLAMIDOL
(DORZOLAMIDE
2% + TIMOLOL 0.5% EYE DROPS)
works
3.
Before
you
use
ZOLAMIDOL
(DORZOLAMIDE 2% + TIMOLOL 0.5%
EYE DROPS)
4.
How
to
use
ZOLAMIDOL
(DORZOLAMIDE 2% + TIMOLOL 0.5%
EYE DROPS)
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ZOLAMIDOL
(DORZOLAMIDE 2% + TIMOLOL 0.5%
EYE DROPS)
8.
Product Description
9.
Manufacturer
and
Product
Registration
Holder
10.
Date of revision
WHAT
ZOLAMIDOL
(DORZOLAMIDE 2% + TIMOLOL
0.5% EYE DROPS) IS USED FOR
ZOLAMIDOL (DORZOLAMIDE 2% +
TIMOLOL
0.5%
EYE
DROPS)
is
comprised
of
two
components.
Dorzolamide
hydrochloride
and
Timolol
maleate.
Dorzolamide
belongs
to
a
group
of
medicines
called
“carbonic
anhydrase
inhibitors”.
Timolol
belongs to a group of
medicines
called “beta blockers”
HOW ZOLAMIDOL (DORZOLAMIDE
2% + TIMOLOL 0.5% EYE DROPS)
WORKS
Each of
these
two components
decrease
elevated intraocular
pressure,
whether
or
not associated with glaucoma,
by reducing
aqueous humor secretion.
BEFORE
YOU
USE
ZOLAMIDOL
(DORZOLAMIDE 2% +
TIMOLOL
0.5% EYE DROPS)
When you must not use it
-
if
you
are
allergic
to
dorzolamide
or
timolol
or
any of
the other ingredients of
this medicine (listed in section 6).
-
if
you
have
now or
had
in
the
past
respiratory problems,
such as
asthma
or
severe
chronic
obstructive
bronchitis
(severe
lung
disease
which
may
cause
wheeziness,
difficulty in breathing and/or
long-standing cough).
-
- if
you
have
a
slow heart
beat,
heart
failure
or
disorders
of
heart
rhythm
(irregular heart beats).
•
- if
you have
severe
kidney disease
or
problems,
or
a prior
history of
kidney
stones
-
- if
you have excess acidity of
the blood
caused by a build up of
chloride in the
blood (hyperchloraemic acidosis).
If you are not sure whether you should use
this
medicine,
contact
your
doctor
or
pharmacist.
_Preg

Termékjellemzők

INDOCO REMEDIES LTD.
PACKAGING DEVELOPMENT DEPARTMENT
PACKAGING MATERIAL SPECIFICATION
Item: Leaflet
A/W Code No.: G2ZAYLL01AESMY
Open Size: 125 x 250 mm
Folding Pattern: H-Unfolded: 250 mm Folded: 20 mm
W-Unfolded: 125 mm Folded: 125 mm
GSM/Paper: 54 Gsm Maplitho Paper
Colour: Pantone 286U
Layout No.:
PGB093130089 LF
APPROVED BY:
PDD: _________________________ HOD: ________
Reason for Preparation:
New Development for
Singapore registration.
For the use of a Registration Medical Practitioner or a Hospital or a
Laboratory
Dorzolamide 2%+Timolol
Eye Drops
0.5%
ZOLAMIDOL
DESCRIPTION
ZOLAMIDOL is comprised of two components: dorzolamide hydrochloride
and timolol maleate. Each of these two components decrease
elevated intraocular pressure, whether or not associated with
glaucoma, by reducing aqueous humor secretion.
It is Clear, colourless to nearly colourless, slightly viscous
solution.
COMPOSITION
Each mL contains: Active: 22.3 mg Dorzolamide Hydrochloride equivalent
to
20mg dorzolamide. 6.83 mg Timolol Maleate equivalent to 5 mg Timolol
Inactives: Hydroxyethyl cellulose, Mannitol, Sodium citrate,Sodium
Hydroxide (to adjust pH) and Water for Injection.
Preservative: 0.075 mg Benzalkonium Chloride
PHARMACOLOGY
Pharmacodynamic Property
ZOLAMIDOL is comprised of two components: dorzolamide hydrochloride
and timolol maleate.
_Dorzolamide hydrochloride_
Dorzolamide hydrochloride is an inhibitor of human carbonic anhydrase
II. Inhibition of carbonic anhydrase in the ciliary processes of the
eye
decreases aqueous humor secretion, presumably by slowing the formation
of bicarbonate ions with subsequent reduction in sodium and fluid
transport.
_Pharmacodynamics_
_Dorzolamide Hydrochloride_
Dorzolamide hydrochloride is a potent inhibitor of human carbonic
anhydrase II. Inhibition of carbonic anhydrase in the ciliary
processes of the
eye decreases aqueous humor secretion, presumably by slowing the
formation of bicarbonate ions with subsequent reduction in sodium and
fluid
transport.
_Timolol Maleate_
Timolol maleate is a non-se