MAXIDEX dexamethasone 0.1% eye drops bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

dexamethasone, Quantity: 1 mg/mL

Disponible desde:

Novartis Pharmaceuticals Australia Pty Ltd

formulario farmacéutico:

Eye Drops, suspension

Composición:

Excipient Ingredients: dibasic sodium phosphate; polysorbate 80; disodium edetate; sodium chloride; benzalkonium chloride; purified water; hypromellose; citric acid monohydrate; sodium hydroxide

Vía de administración:

Ophthalmic

Unidades en paquete:

5mL

clase:

Medicine Registered

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

INDICATIONS AS AT 16 JAN 2005 : Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in oedema and inflammation; acute and chronic anterior uveitis; corneal injury from chemical radiation or thermal burns or penetration of foreign bodies.

Resumen del producto:

Visual Identification: white to pale yellow, opaque suspension with no agglomerates; Container Type: Bottle; Container Material: LDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

1991-10-15

Información para el usuario

MAXIDEX
® EYE DROPS
0.1%
_Dexamethasone_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU START TO USE MAXIDEX EYE
DROPS.
This leaflet answers some common
questions about Maxidex 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
WWW.NOVARTIS.COM.AU
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 Maxidex
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 MAXIDEX IS USED
FOR
Maxidex contains dexamethasone
which is a type of cortisone. It
belongs to the group of medicines
called corticosteroids
Maxidex is used to treat:
•
the redness, swelling and other
symptoms due to inflammation or
allergy of the eye
•
injury of the cornea caused by
chemical, heat burns or foreign
bodies.
Before prescribing Maxidex Eye
Drops for you, your doctor will have
examined your eye(s) and decided
that Maxidex Eye Drops is the right
medicine for you.
Your doctor may have prescribed
Maxidex for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MAXIDEX HAS
BEEN PRESCRIBED FOR YOU.
Maxidex is not addictive.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN_
Maxidex is not for use in children.
The safety and effectiveness of
Maxidex in children has not been
established.
BEFORE YOU USE
MAXIDEX
_WHEN YOU MUST NOT USE IT_
DO NOT USE MAXIDEX IF YOU HAVE AN
ALL

Ficha técnica

1
AUSTRALIAN PI – MAXIDEX
® (DEXAMETHASONE) EYE DROPS
1
NAME OF THE MEDICINE
Dexamethasone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Maxidex Eye Drops contain 1 mg/mL dexamethasone and is preserved with
benzalkonium chloride
(0.1 mg/mL).
May contain potential allergen sulfites from the manufacturing
process.
For a full list of excipients see section 6.1 ‘LIST OF
EXCIPIENTS’.
3
PHARMACEUTICAL FORM
Maxidex Eye Drops is a white to pale yellow, opaque suspension with no
agglomerates and is
presented in a DROP-TAINER
®
bottle.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Steroid responsive inflammatory conditions of the palpebral and bulbar
conjunctiva, cornea and
anterior segment of the globe, such as allergic conjunctivitis, acne
rosacea, superficial punctate
keratitis, herpes zoster keratitis, iritis, cyclitis, selected
infective conjunctivitis when the inherent
hazard of steroid use is accepted to obtain an advisable diminution in
oedema and inflammation;
corneal injury from chemical radiation or thermal burns or penetration
of foreign bodies.
4.2
D
OSE AND METHOD OF ADMINISTRATION
One or two drops topically in the conjunctival sac(s). In severe
disease, drops may be used hourly,
being tapered to discontinuation as the inflammation subsides. In mild
disease, drops may be used
up to four to six times daily.
Nasolacrimal occlusion or gently closing the eyelid after
administration is recommended. This may
reduce the systemic absorption of medicinal products administered via
the ocular route and result in
a decrease in systemic adverse reactions.
INSTRUCTIONS TO PATIENTS
SHAKE BOTTLE WELL BEFORE USING.
No contact lenses should be worn under Maxidex Eye Drops treatment
(see Section 4.4 Special
Warnings and Precautions for Use).
To prevent contaminating the dropper tip and solution, care should be
taken not to touch the eyelids or
surrounding areas with the dropper tip of the bottle.
If
more
than
1
topical
ophthalmic
medicinal
product
is
being
used,
the
medicines
must
be
administered at least 5 minutes a