Latanoprost/Timolol Sandoz 50/5 latanoprost 50 microgram/mL timolol 5 mg/mL Eye Drops

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

latanoprost,timolol maleate

可用日期:

Sandoz Pty Ltd

INN（国际名称）:

Latanoprost,Timolol maleate

授权状态:

Registered

资料单张

LATANOPROST /
TIMOLOL SANDOZ
®
_Latanoprost/Timolol maleate Eye Drops_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Latanoprost/Timolol
Sandoz Eye drops. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Latanoprost/
Timolol Sandoz Eye drops against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LATANOPROST/
TIMOLOL SANDOZ EYE
DROPS IS USED FOR
This medicine is used to treat lower
raised pressure in the eye and to treat
glaucoma. Glaucoma is a condition
in which the pressure of fluid in the
eye may be high. However, some
people with glaucoma may have
normal eye pressure.
Glaucoma is usually caused by a
build up of the fluid which flows
through the eye. This build up occurs
because the fluid drains out of your
eye more slowly than it is being
pumped in. Since new fluid continues
to enter the eye, joining the fluid
already there, the pressure continues
to rise. This raised pressure may
damage the back of the eye resulting
in gradual loss of sight. Damage can
progress so slowly that the person is
not aware of this gradual loss of
sight. Sometimes even normal eye
pressure is associated with damage to
the back of the eye. There are usually
no symptoms of glaucoma. If
glaucoma is not treated it can lead to
serious problems, including total
blindness. In fact, untreated
glaucoma is one of the most common
causes of blindness.
It contains two active ingredients,
latanoprost and timolol maleate.
Latanoprost belongs to a group of
medicines called prostaglandin
agonists. Latanoprost works by
allowing more fluid to flow out from
within your eye(s).
Timolol maleate belongs to a family
of medicines called beta blockers.
Timolol maleate lowers the pressure
in the e

产品特点

_Product Information _
_Page 1 _
_Latanoprost/Timolol Sandoz 50/5 Eye Drops _
_February 2016 _
_Sandoz Pty Ltd _
_ _
_Version 03 _
_ _
PRODUCT INFORMATION
LATANOPROST / TIMOLOL SANDOZ
® 50/5 EYE DROPS
NAME OF THE MEDICINE
Latanoprost/Timolol Sandoz 50/5 is a combination eye drop containing
latanoprost and
timolol maleate.
_ _
LATANOPROST
Chemical name: Isopropyl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-
[(3R)3-hydroxy-5-
phenylpentyl]-cyclopentyl]-5-heptenoate.
The CAS number for Latanoprost is 130209-82-4
Empirical formula:
C
26
H
40
O
5
MW:
432.59
TIMOLOL MALEATE
Chemical
name:
(S)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-
propanol maleate (1:1) (salt).
The CAS number for timolol maleate is 26921-17-5.
Empirical formula: C
13
H
24
N
4
O
3
S . C
4
H
4
O
4
MW:
432.49
_Product Information _
_Page 2 _
_Latanoprost/Timolol Sandoz 50/5 Eye Drops _
_February 2016 _
_Sandoz Pty Ltd _
_ _
_Version 03 _
_ _
DESCRIPTION
Latanoprost/Timolol
Sandoz
50/5
Eye
Drops
is
a
sterile
solution
containing
50
micrograms/mL of latanoprost and 5 mg/mL of timolol (6.83 mg timolol
maleate) in an
aqueous buffer solution pH 6.0.
Latanoprost is a prostaglandin F
2α
analogue. Sixty four isomers of latanoprost are possible
however it is purified as a single isomer. Latanoprost is a colourless
to pale yellowish viscous
oil. Latanoprost is practically insoluble in water, freely soluble in
ethanol, ethyl acetate,
isopropanol, methanol, acetone, octanol and is very soluble in
acetonitrile.
Timolol maleate is a beta-adrenergic receptor blocking agent. Timolol
maleate is a white or
almost white, crystalline powder. It is freely soluble in water and
ethanol, sparingly soluble in
chloroform, very slightly soluble in cyclohexane and insoluble in
isooctane and ether.
The excipients in Latanoprost/Timolol Sandoz 50/5 Eye Drops are
benzalkonium chloride
(0.2 mg/mL) as a preservative, dibasic anhydrous sodium phosphate,
monobasic dihydrate
sodium phosphate, sodium chloride and water for injections.
PHARMACOLOGY
PHARMACODYNAMICS
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