MYDRIACYL tropicamide 1% eye drops bottle

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

tropicamide, Quantity: 10 mg/mL

제공처:

Alcon Laboratories Australia Pty Ltd

약제 형태:

Eye Drops, solution

구성:

Excipient Ingredients: sodium chloride; benzalkonium chloride; purified water; disodium edetate; hydrochloric acid; sodium hydroxide

관리 경로:

Ophthalmic

패키지 단위:

15mL

수업:

Medicine Registered

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

INDICATIONS AS AT 14 JULY 2003 : Used to produce mydriasis and cycloplegia for diagnostic purposes.

제품 요약:

Visual Identification: Clear solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

1991-10-15

환자 정보 전단

MYDRIACYL™ EYE DROPS
1
MYDRIACYL™ EYE
DROPS
_Tropicamide Ophthalmic Solution 0.5% & 1.0% _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
READ THIS LEAFLET CAREFULLY BEFORE
YOU START TO USE MYDRIACYL EYE
DROPS.
This leaflet answers some common
questions about Mydriacyl Eye
Drops. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET FROM
TGA eBusiness Services
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Mydriacyl
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 YOUR
MEDICINE.
You may need to read it again.
WHAT MYDRIACYL IS
USED FOR
Mydriacyl is used alone or in
combination with other eye
drops/medicines to enlarge (dilate)
the pupil and to prevent the eye from
focusing. Your doctor may use
Mydriacyl prior to either a surgical
procedure or examination of the eye.
Mydriacyl Eye Drops contain the
active ingredient tropicamide, which
belongs to a class of medicines
known as "anticholinergics".
Ask your doctor if you have any
questions about why Mydriacyl has
been prescribed for you.
Your doctor may have prescribed it
for another reason.
_USE IN CHILDREN _
Mydriacyl is not for use in children.
The safety and effectiveness of
Mydriacyl in children has not been
established.
BEFORE YOU USE
MYDRIACYL
_WHEN YOU MUST NOT USE IT _
DO NOT USE MYDRIACYL EYE DROPS IF:
•
You are allergic to tropicamide or
to any of the ingredients in
Mydriacyl Eye Drops listed at the
end of this leafl

제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION - MYDRIACYL
TM (TROPICAMIDE)
EYE DROPS, SOLUTION
1
NAME OF THE MEDICINE
Tropicamide 0.5% Eye Drops
Tropicamide 1.0 % Eye Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MYDRIACYL Eye Drops contain either 5 mg/mL (0.5%) or 10 mg/mL (1.0%)
tropicamide.
The solution is preserved with benzalkonium chloride (0.01%).
For a full list of excipients see Section 6.1. List of Excipients.
3
PHARMACEUTICAL FORM
Eye drops.
MYDRIACYL Eye Drops is a sterile, multi-dose ophthalmic solution for
topical administration
in the eye, available in two strengths.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MYDRIACYL Eye Drops are used to produce mydriasis and cycloplegia for
diagnostic
purposes.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
For refraction, instil one or two drops of 1% solution in eye(s),
repeated in five minutes. If patient
is not seen within 20 to 30 minutes, an additional drop may be
instilled to prolong mydriatic
effect. For examination of fundus, one or two drops of 0.5% solution,
15 or 20 minutes prior to
examination. Individuals with heavily pigmented irides may require
higher strength or more
doses.
In order to minimise systemic absorption, apply pressure to the tear
duct for one minute
immediately after administration.
If more than one topical ophthalmic product is being used, the
products must be administered at
least 5 minutes apart. Eye ointments should be administered last.
4.3 CONTRAINDICATIONS
MYDRIACYL should not be used:
o
in patients with glaucoma or with a narrow anterior chamber angle
o
in individuals known to be hypersensitive to any component of the
preparation. (See
Section 6.1. List of excipients).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR TOPICAL OPHTHALMIC USE ONLY - NOT FOR INJECTION.
Tropicamide may cause increased intraocular pressure. The possibility
of undiagnosed glaucoma
and because of the risk of precipitating angle-closure glaucoma in the
elderly and others prone
to raised intraocular pressure, an estimate of the depth of the angle
of the anterior