Maxitrol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dexamethasone 1 mg/mL;  ; Neomycin sulfate 3500 IU/mL; Polymyxin B sulfate 6000 IU/mL

Available from:

Novartis New Zealand Ltd

INN (International Name):

Dexamethasone 1 mg/mL

Pharmaceutical form:

Eye drops, suspension

Composition:

Active: Dexamethasone 1 mg/mL   Neomycin sulfate 3500 IU/mL Polymyxin B sulfate 6000 IU/mL Excipient: Benzalkonium chloride as a solution Hydrochloric acid Hypromellose Polysorbate 20 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 - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1968-02-08

Patient Information leaflet

Internal document code
Maxtd290623cNZ based on DS maxt290623iNZ
1
MAXITROL™ EYE DROPS
_Dexamethasone, Neomycin and Polymyxin B _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE YOU START TO USE
MAXITROL EYE DROPS.
This leaflet answers some
common questions about
Maxitrol 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
Maxitrol against the expected
benefits it will have for you.
The information in this leaflet
applies to Maxitrol Eye Drops
only. This information does not
apply to similar products, even if
they contain the same
ingredients.
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 MAXITROL EYE
DROPS IS USED FOR
Maxitrol Eye Drops is a sterile
eye drop that contains the active
ingredients dexamethasone,
neomycin and polymyxin B.
Both neomycin and polymyxin
B are antibiotic agents.
Dexamethasone is a type of
cortisone and belongs to the
group of medicines called
corticosteroids.
Maxitrol Eye Drops are used to
treat inflammation and bacterial
infections in the external part of
the eye.
Before prescribing Maxitrol Eye
Drops, your doctor will have
examined your eye(s) and
decided that Maxitrol Eye Drops
is the right medicine for you.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Maxitrol
TM
sterile ophthalmic suspension
Maxitrol
TM
sterile ophthalmic ointment.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Maxitrol Ophthalmic Suspension contains dexamethasone 1 mg,
neomycin
sulfate 3,500 IU, polymixin B sulfate 6,000 IU.
Each g of Maxitrol Ophthalmic Ointment contains Dexamethasone 1 mg,
neomycin sulfate
3,500 IU, polymixin B sulfate 6,000 IU.
Excipient with known effect
Eye Drops: Benzalkonium chloride 0.004% as a preservative.
Eye Ointment: Methyl hydroxybenzoate 0.05% as a preservative.
Propyl hydroxybenzoate 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
Maxitrol is indicated in ocular inflammation when concurrent use of an
antimicrobial
is judged necessary.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Keep out of reach of children.
If more than 1 topical ophthalmic medicinal product is being used, the
medicines must be
administered at least 5 minutes apart. Ointments should be
administered last.
Maxitrol Eye Drops
One to 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.
Shake the bottle well before use. Remove the loose collar from the cap
when the bottle is
first opened. After cap is removed, if tamper evident snap collar is
loose, remove before
using product.
In order to prevent contamination of the dropper tip and the
suspension, caution should be
exercised to ensure that the dropper tip does not touch the eyelids,
the surroundings of the
eye, or any other surfaces.
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.
2
Maxitrol Eye Ointment
Appl