COSOPT PRESERVATIVE-FREE dorzolamide (as hydrochloride) 20mg/mL and timolol (as maleate) 5mg/mL single dose eye drop ampoule

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

timolol maleate, Quantity: 6.83 mg/mL (Equivalent: timolol, Qty 5 mg/mL); dorzolamide hydrochloride, Quantity: 22.26 mg/mL (Equivalent: dorzolamide, Qty 20 mg/mL)

Inapatikana kutoka:

Mundipharma Pty Ltd

INN (Jina la Kimataifa):

Dorzolamide hydrochloride,Timolol maleate

Dawa fomu:

Eye Drops, solution

Tungo:

Excipient Ingredients: mannitol; sodium hydroxide; water for injections; hyetellose; sodium citrate dihydrate

Njia ya uendeshaji:

Ophthalmic

Vitengo katika mfuko:

60 x 0.2mL ampoules, 15 x 0.2mL ampoules (starter pack)

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Cosopt Preservative Free is indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when concominant therapy is appropriate.

Bidhaa muhtasari:

Visual Identification: Clear, colourless to nearly colourless, slightly viscous solution.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Registered

Idhini ya tarehe:

2011-04-07

Taarifa za kipeperushi

COSOPT
®
PRESERVATIVE FREE
1
COSOPT
®
Preservative
Free
Preservative Free Dorzolamide hydrochloride/Timolol maleate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about COSOPT-
Preservative Free. 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 using COSOPT-
Preservative Free against the benefits
they expect it will have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What COSOPT-
Preservative Free is
used for
COSOPT-Preservative Free is used
to lower raised pressure in the eye
and to treat glaucoma for patients
who might be sensitive to
preservative-containing formulations
or for whom the use of a preservative
free formulation is otherwise
advisable. 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. Also, some people with
raised eye pressure may not have
glaucoma.
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. The only way of knowing
that you have glaucoma is to have
your eye pressure, optic nerve and
visual field checked by an eye
specialist or optometrist. If glaucoma
is not treated it can lead to serious
problems. You may have no
symptoms but eventually glaucoma
can

Tabia za bidhaa

COSOPT PRESERVATIVE FREE® EYE DROPS
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – COSOPT

PRESERVATIVE
FREE [DORZOLAMIDE (AS HYROCHLORIDE) AND TIMOLOL (AS
MALEATE)] SINGLE DOSE EYE DROPS
1
NAME OF THE MEDICINE
Dorzolamide hydrochloride and timolol maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
COSOPT Preservative Free is supplied as a sterile, isotonic, buffered,
slightly viscous, aqueous
solution. Each millilitre of COSOPT Preservative Free contains 20.00
mg (2.0% w/v)
dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5.00 mg (0.5%
w/v) timolol (6.83
mg of timolol maleate) as the active ingredients.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to nearly colourless, slightly viscous solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
COSOPT Preservative Free is indicated in the treatment of elevated
intraocular pressure (IOP)
in patients with ocular hypertension or open-angle glaucoma when
concomitant therapy is
appropriate.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dose is one drop of COSOPT Preservative Free in the affected
eye(s) two times daily.
When substituting COSOPT for another ophthalmic antiglaucoma agent(s),
discontinue the
other agent(s) after proper dosing on one day, and start COSOPT
Preservative Free on the next
day.
If another topical ophthalmic agent is being used, COSOPT Preservative
Free and the other agent
should be administered at least ten minutes apart.
Efficacy in paediatric patients has not been established. Safety in
paediatric patients below the
age of 2 years has not been established (For information regarding
safety in paediatric patients
≥2 and <6 years of age, see Section 4.4 Special Warnings and
Precautions for Use/Paediatric
Use).
COSOPT Preservative Free is a sterile solution that does not contain a
preservative. The solution
from one individual unit is to be used immediately after opening for
administration to one or
COSOPT PRESERVATIVE FREE® EYE DROPS
Page 2 of 14