Trusopt

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Dorzolamide hydrochloride 2.226%{relative} equivalent to dorzolamide base 2%

から入手可能:

Mundipharma New Zealand Ltd

INN（国際名）:

Dorzolamide hydrochloride 2.226% w/v (=dorzolamide base 2%)

投薬量:

2 %

医薬品形態:

Eye drops, solution

構図:

Active: Dorzolamide hydrochloride 2.226%{relative} equivalent to dorzolamide base 2% Excipient: Benzalkonium chloride Hyetellose Mannitol Sodium citrate dihydrate Sodium hydroxide Water for injection

パッケージ内のユニット:

Bottle, plastic, Sample pack, 5 mL

クラス:

Prescription

処方タイプ:

Prescription

製:

F.I.S. Fabbrica Italiana Sintetici SpA

適応症:

TRUSOPT Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with: · ocular hypertension · open-angle glaucoma · pseudoexfoliative glaucoma and other secondary open-angle glaucomas · in the short-term treatment of paediatric glaucomas as adjunctive therapy to beta-blockers and for monotherapy when other treatments have proved ineffective or are unsuitable.

製品概要:

Package - Contents - Shelf Life: Bottle, plastic, Sample pack - 5 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, Occumeter Plus - HDPE (Lupolen - 5 mL - 24 months from date of manufacture stored at or below 30°C

承認日:

1993-12-21

情報リーフレット

TRUSOPT
®
_dorzolamide hydrochloride_
5 mL Ophthalmic solution
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about TRUSOPT. 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
TRUSOPT 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 TRUSOPT IS USED FOR
TRUSOPT 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 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 TRUSOPT helps control your glaucoma it does not cure it.
For more information about glaucoma, contact Glaucoma New Zealand,
Department of
Ophthalmology, Private Bag 92019, Auckland, telephone [phone],
em

製品の特徴

NEW ZEALAND DATA SHEET
TRUSOPT 2% Ophthalmic Solution
05 May 2017
Page 1 of 9
TRUSOPT® 2% OPHTHALMIC SOLUTION
dorzolamide hydrochloride
1 TRUSOPT 2% OPTHALMIC SOLUTION
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1mL of TRUSOPT 2% contains 20 mg dorzolamide (22.3 mg of
dorzolamide hydrochloride).
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
TRUSOPT ophthalmic Solution is a sterile, isotonic, buffered, slightly
viscous aqueous solution
available in a 5mL translucent plastic dispensing bottle with an
opaque white cap.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TRUSOPT Ophthalmic Solution is indicated in the treatment of elevated
intraocular pressure in
patients with:
•
ocular hypertension
•
open-angle glaucoma
•
pseudoexfoliative glaucoma and other secondary open-angle glaucomas
•
in the short-term treatment of paediatric glaucomas as adjunctive
therapy to beta-
blockers and for monotherapy when other treatments have proved
ineffective or are
unsuitable.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSE _
When used as monotherapy, the dose is one drop of TRUSOPT Ophthalmic
Solution in the affected
eye(s) three times daily.
When used as adjunctive therapy with an ophthalmic beta-blocker, the
dose is one drop of TRUSOPT
in the affected eye(s) two times daily.
_PAEDIATRIC POPULATION _
In paediatric patients, when used as monotherapy and when used as
adjunctive therapy, the dose is
one drop of TRUSOPT in the affected eye(s) three times daily.
_METHOD OF ADMINISTRATION _
When substituting TRUSOPT for another ophthalmic anti-glaucoma agent,
discontinue the other
agent after proper dosing on one day, and start TRUSOPT on the next
day.
If more than one topical ophthalmic medicine is being used, the
medicines should be administered
at least ten minutes apart.
NEW ZEALAND DATA SHEET
TRUSOPT 2% Ophthalmic Solution
05 May 2017
Page 2 of 9
4.3
CONTRAINDICATIONS
TRUSOPT is contraindicated in patients who are hypersensitive to any
component of this product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS