Dortimopt

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Dorzolamide hydrochloride 22.26 mg/mL equivalent to dorzolamide 20 mg/mL; Timolol maleate 6.83 mg/mL equivalent to timolol 5 mg/mL

Beszerezhető a:

Viatris Limited

INN (nemzetközi neve):

Dorzolamide hydrochloride 22.26 mg/mL (equivalent to dorzolamide 20 mg/mL)

Adagolás:

20 mg/mL + 5 mg/mL

Gyógyszerészeti forma:

Eye drops, solution

Összetétel:

Active: Dorzolamide hydrochloride 22.26 mg/mL equivalent to dorzolamide 20 mg/mL Timolol maleate 6.83 mg/mL equivalent to timolol 5 mg/mL Excipient: Benzalkonium chloride Hyetellose Mannitol Sodium citrate Sodium hydroxide Water for injection

db csomag:

Bottle, plastic, white, opaque with a sealed dropper tip and a cap with a tamper proof seal, 5 mL

Osztály:

Prescription

Recept típusa:

Prescription

Gyártó:

Crystal Pharma SA

Terápiás javallatok:

Indicated for the treatment of elevated intraocular pressure (IOP) in patients with: · ocular hypertension · open-angle glaucoma · pseudoexfoliative glaucoma · other secondary open-angle glaucoma and who are: · insufficiently responsive to topical beta blocker monotherapy · currently receiving concomitant antiglaucoma therapies such as dorzolamide HCl and timolol maleate

Termék összefoglaló:

Package - Contents - Shelf Life: Bottle, plastic, white, opaque with a sealed dropper tip and a cap with a tamper proof seal - 5 mL - 36 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C

Engedély dátuma:

2011-06-02

Betegtájékoztató

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
DORTIMOPT
_DORZOLAMIDE (AS HYDROCHLORIDE) 20 MG/ML_
_AND TIMOLOL (AS MALEATE) 5 MG/ML EYE DROPS_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using Dortimopt.
This leaflet answers some common
questions about Dortimopt 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 using Dortimopt
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 DORTIMOPT IS
USED FOR
Dortimopt 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 Dortimopt helps control
y

Termékjellemzők

Page 1 of 11
NEW ZEALAND DATA SHEET
DORTIMOPT
1. PRODUCT NAME
DORTIMOPT 20 mg/ml + 5 mg/ml eye drops solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of eye drops solution contains 20 mg of dorzolamide (22.26 mg
dorzolamide hydrochloride)
and 5 mg of timolol (6.83 mg of timolol maleate).
Excipient with known effect: benzalkonium chloride 0.075 mg/ml as a
preservative.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
A clear, nearly colourless to colourless, slightly viscous solution.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
DORTIMOPT is indicated for the treatment of elevated intraocular
pressure (IOP) in patients with:

ocular hypertension

open-angle glaucoma

pseudoexfoliative glaucoma

or other secondary open-angle glaucoma’s
and who are:

insufficiently responsive to topical beta blocker monotherapy

currently receiving concomitant antiglaucoma therapies such as
dorzolamide
hydrochloride and timolol maleate.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
The dose is one drop of DORTIMOPT in the affected eye(s) two times
daily.
When substituting DORTIMOPT for another ophthalmic antiglaucoma
agent(s), discontinue the other
agent(s) after proper dosing on one day, and start DORTIMOPT on the
next day.
If another topical ophthalmic agent is being used, DORTIMOPT and the
other agent should be
administered at least ten minutes apart.
Page 2 of 11
_PAEDIATRIC POPULATION_
Safety and efficacy in paediatric patients below the age of 2 years
have not been established. (For
information regarding use in paediatric patients ≥ 2 years of age
and < 6 years see section 4.4).
METHOD OF ADMINISTRATION
The solution is applied as a drop to the affected eye(s).
_4.3_
_CONTRAINDICATIONS_
DORTIMOPT is contraindicated in patients with:

reactive airway disease, bronchial asthma or a history of bronchial
asthma, other
obstructive lung disorders or a history of bronchospasm

uncontrolled heart failure (see section 4.4)

cardiogenic shock

sick sinus