Maxidex

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dexamethasone 1 mg/mL;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Dexamethasone 1 mg/mL (5% overage added)

Dosage:

0.1 %

Pharmaceutical form:

Eye drops, suspension

Composition:

Active: Dexamethasone 1 mg/mL   Excipient: Benzalkonium chloride Citric acid monohydrate Dibasic sodium phosphate Disodium edetate dihydrate Hypromellose Polysorbate 80 Purified water Sodium chloride Sodium hydroxide

Units in package:

Bottle, dropper, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, - 5 mL - 18 months from date of manufacture stored at or below 25°C. Do not freeze. 28 days opened stored at or below 25°C. Do not freeze.

Authorization date:

1969-12-31

Patient Information leaflet

Internal document code
1
maxd221222cNZ
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.medsafe.govt.nz.
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 MU

Summary of Product characteristics

Internal document code
1
max221222iNZ
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Maxidex
TM
dexamethasone
0.1% sterile ophthalmic suspension
Maxidex
TM
dexamethasone
0.1% sterile ophthalmic ointment.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Maxidex Ophthalmic Suspension contains Dexamethasone 1 mg.
Each g of Maxidex Ophthalmic Ointment contains Dexamethasone 1 mg.
Excipient with known effect
Eye Drops: Benzalkonium chloride 0.1 mg in 1.0 mL (0.01%) as a
preservative.
Eye Ointment: Methyl hydroxybenzoate 0.5 mg in 1 g (0.05%) as a
preservative
Propyl hydroxybenzoate 0.1 mg in 1 g (0.01%) as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension.
Eye ointment.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Steroid responsive inflammatory
conditions of the palpebral and bulbar conjunctiva,
cornea and anterior segment of the globe. These include allergic
conjunctivitis, acne
rosacea, superficial punctate keratitis, herpes zoster keratitis,
iritis, cyclitis, selected
infective conjunctivitides 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. May be
used to suppress
graft reaction after keratoplasty.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Maxidex Ophthalmic Suspension
Shake well before using.
Topical application: One or two drops in the conjunctival sac.
_Severe or Acute Inflammation _
Every 30 to 60 minutes as initial therapy, reducing the dosage when
favorable response
is observed to every two to four hours. Further reduction may be made
to one drop three
or four times daily if sufficient to control inflammation. If
favorable response is not
obtained in three to four days, additional systemic or conjunctival
therapy may be
indicated.
_Chronic Inflammation _
Every three to six hours, or as frequently as necessary.
_Allergies or Minor Inflammation _
Every three to four hours until the desired