Maxitrol 0.1% w/v, 6000 IU/ml, 3500 IU/ml eye drops, suspension

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Dexamethasone; Polymyxin b sulfate; Neomycin sulfate

Inapatikana kutoka:

Novartis Ireland Limited

ATC kanuni:

S01CA; S01CA01

INN (Jina la Kimataifa):

Dexamethasone; Polymyxin b sulfate; Neomycin sulfate

Kipimo:

0.1% w/v, 6000 IU/ml, 3500 IU/ml percent weight/volume

Dawa fomu:

Eye drops, suspension

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Corticosteroids and antiinfectives in combination; dexamethasone and antiinfectives

Idhini hali ya:

Not marketed

Idhini ya tarehe:

1988-04-01

Taarifa za kipeperushi

1
PACKAGE LEAFLET - INFORMATION FOR THE USER
MAXITROL® 0.1 % W/V, 6000 IU/ML, 3500 IU/ML EYE DROPS, SUSPENSION
dexamethasone, polymyxin B sulphate, neomycin sulphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU..
-
KEEP THIS LEAFLET.
You may need to read it again.
-
IF YOU HAVE ANY FURTHER QUESTIONS,
ask your doctor or your pharmacist.
-
This medicine has been prescribed for you only.
DO NOT PASS IT ON TO OTHERS.
It may harm them,
even if their signs of illness are the same as yours.
IF YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR OR PHARMACIST. THIS
INCLUDES ANY POSSIBLE SIDE
EFFECTS NOT LISTED IN THIS LEAFLET.
WHAT IS IN THIS LEAFLET
1.
WHAT MAXITROL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MAXITROL
3.
HOW TO USE MAXITROL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MAXITROL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT MAXITROL IS AND WHAT IT IS USED FOR
MAXITROL
contains a steroid, dexamethasone and two antibiotics, neomycin
sulphate and
polymyxin B sulphate.
IT IS USED FOR THE SHORT TERM TREATMENT
of inflammation of the eye, where administration of an
antibiotic is also required to prevent an eye infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MAXITROL
DO NOT USE MAXITROL...
-
If you have
ANY TYPE OF INFECTION
of the eye that is not being treated including viral, fungal or
untreated parasitic eye infections or Tuberculosis of the eye. Use of
steroids may make
infections worse.
-
If you are
ALLERGIC
to dexamethasone, polymyxin B, neomycin or to any of the other
ingredients
listed in section 6.
Ask your doctor for advice.
TAKE SPECIAL CARE...
-
Only use MAXITROL in your eye(s).
-
Consult your doctor or pharmacist before using this medicine if you
have a disorder causing a
THINNING OF THE EYE TISSUES.
-
If you experience
ALLERGIC REACTIONS
with MAXITROL, discontinue use and consult your
doctor. Allergic reactions may vary from localized itching or skin
redness to severe allergic
reactions (anaphylactic

Tabia za bidhaa

Health Products Regulatory Authority
12 February 2024
CRN00F22Y
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxitrol 0.1% w/v, 6000 IU/ml, 3500 IU/ml eye drops, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml suspension contains 1 mg dexamethasone, 6000 IU polymyxin B
sulphate, 3500 IU neomycin sulphate (as base).
Excipients with known effect:
0.04mg Benzalkonium Chloride
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, suspension
White to pale yellow opaque suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Maxitrol Eye Drops is indicated for the short-term treatment of
steroid responsive conditions of the eye when prophylactic
antibiotic treatment is also required, after excluding the presence of
fungal and viral disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Children and Adults (including the Elderly)
Apply one or two drops to each affected eye up to six times daily or,
more frequently if required.
Heptic and renal impairment
Maxitrol Eye Drops has not been studied in these subject populations.
Method of administration

For ocular use only. Not for injection or ingestion.

Shake the bottle well before use.

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.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients.

Herpes simplex keratitis.

Vaccinia, varicella, and other viral infection of cornea or
conjunctiva.

Fungal diseases of ocular structures or untreated parasiti