COSDOR dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drop bottle

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

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)

Dostopno od:

Viatris Pty Ltd

INN (mednarodno ime):

Dorzolamide hydrochloride,Timolol maleate

Farmacevtska oblika:

Eye Drops

Sestava:

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

Pot uporabe:

Ophthalmic

Enote v paketu:

1

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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

Povzetek izdelek:

Visual Identification: Clear, slightly viscous, colorless aqueous solution; Container Type: Bottle; Container Material: PE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2014-09-25

Navodilo za uporabo

COSDOR
_Dorzolamide hydrochloride/Timolol maleate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COSDOR. 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 COSDOR
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 COSDOR IS
USED FOR
COSDOR is used to 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. 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 lead to total blindness. In fact,
untreated glaucoma is one of the
most common causes of blindness.
Although COSDOR helps control
your glaucoma it does not cure it.
For more information about
glaucoma, contact Glaucoma
Australia Inc., PO Box 420, Crows
Nest 1585, telephone [phone].
COSDOR c

Lastnosti izdelka

AUSTRALIAN PRODUCT INFORMATION
COSDOR
_(dorzolamide hydrochloride and timolol maleate) eye drops _
1
NAME OF THE MEDICINE
Dorzolamide hydrochloride and timolol maleate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
COSDOR is supplied as a sterile, isotonic, buffered, slightly viscous,
aqueous solution. Each millilitre of
COSDOR 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, slightly viscous, colourless aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COSDOR 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
DOSE AND METHOD OF ADMINISTRATION
For individual patient use only.
The dose is one drop of COSDOR in the affected eye(s) two times daily.
When substituting COSDOR for another ophthalmic antiglaucoma agent(s),
discontinue the other agent(s)
after proper dosing on one day, and start COSDOR on the next day.
If another topical ophthalmic agent is being used, COSDOR 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).
4.3
CONTRAINDICATIONS
COSDOR is contraindicated in patients with:
•
reactive airway disease, bronchial asthma or a history of bronchial
asthma, or severe chronic obstructive
pulmonary disease
•
sinus bradycardia, sino-atrial block, second or third degree
atrioventricular block, overt cardiac failure,
cardiogenic shock
•
hypersensitivity to any component of this product
The above are based on the components and a