LATANOPROST SANDOZ latanoprost 50 micrograms/mL eye drop solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

latanoprost, Quantity: 0.05 mg/mL

Available from:

Sandoz Pty Ltd

INN (International Name):

Latanoprost

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: sodium chloride; dibasic sodium phosphate; benzalkonium chloride; water for injections; monobasic sodium phosphate monohydrate

Administration route:

Ophthalmic

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Product summary:

Visual Identification: Each 5mL LDPE bottle contains 2.5mL clear colourless eye drop solution.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-09-29

Patient Information leaflet

LATANOPROST SANDOZ
®
1
LATANOPROST
SANDOZ
®
_Latanoprost Eye Drops Solution _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Latanoprost Sandoz.
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 this medicine
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
SANDOZ 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.
_ _
_HOW LATANOPROST SANDOZ _
_WORKS_
_ _
It contains the active ingredient
latanoprost. Latanoprost belongs to a
group of medicines called
prostaglandin agonists.
It works by lowering the pressure in
the eye by allowing more fluid to
flow out from within your eye.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescrib

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION
LATANOPROST SANDOZ
® (LATANOPROST) EYE DROPS, SOLUTION
1.
NAME OF THE MEDICINE
Latanoprost
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Latanoprost Sandoz Eye Drops is a sterile, isotonic solution
containing 50 micrograms/mL of
latanoprost in an aqueous solution of pH 6.7.
Each
5
mL
polyethylene
bottle
contains
2.5
mL
clear
colourless
eye
drop
solution
corresponding to a minimum of 80 drops of solution. One drop contains
approximately 1.5
micrograms latanoprost.
_Excipients with known effect:_
benzalkonium chloride.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear and colourless liquid, filled in a
polyethylene container.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open-angle
glaucoma or ocular
hypertension.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_RECOMMENDED DOSAGE FOR ADULTS (INCLUDING THE ELDERLY) _
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is
obtained if Latanoprost Sandoz is administered in the evening.
Systemic absorption can be
minimised by pressure on the tear duct immediately after application
of the eye drop.
If one dose is missed, treatment should continue with the next dose as
normal.
The dosage of Latanoprost Sandoz should not exceed once daily since it
has been shown that
more frequent administration decreases the intraocular pressure
lowering effect.
METHOD OF ADMINISTRATION
Latanoprost Sandoz is effective as a single drug therapy but can also
be used in combination
with beta-adrenergic antagonists (timolol), adrenergic agonists
(dipivefrine hydrochloride),
cholinergic
agonists
(pilocarpine)
and
carbonic
anhydrase
inhibitors
(acetazolamide)
to
achieve an additive effect. In case of combined therapy the eye drop
products should be
administered with an interval of at least five minutes.
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