FML-NEO LIQUIFILM OPHTHALMIC SUSPENSION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Abbvie (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

SUSPENSION

Composition:

EACH 1 ml OPHTHALMIC SUSPENSION CONTAINS FLUOROMETHOLONE 1,1 mg NEOMYCIN SULPHATE EQUIVALENT TO 3,85 mg/ml NEOMYCIN

Authorization status:

Registered

Authorization date:

1978-07-12

Patient Information leaflet

AbbVie (Pty) Ltd
FML-NEO Liquifilm Ophthalmic Suspension
Fluorometholone 1,0 mg/ml
Neomycin sulphate equivalent to neomycin base 3,5 mg/ml
1.3.2 Patient Information Leaflet
Page 1 of 3
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
FML-NEO
™ LIQUIFILM OPHTHALMIC SUSPENSION, fluorometholone 1,0 mg/ml and
neomycin
sulfate (equivalent to 3,5 mg neomycin base) 5 mg/ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING FML-NEO
™

Keep this leaflet. You may need to read it again

If you have further questions, please ask your doctor or pharmacist.

FML-NEO
™
has been prescribed for you personally and you should not share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
1. WHAT FML-NEO
™ CONTAINS
The active substances of FML-NEO
™
are fluorometholone 1,0 mg/ml and neomycin sulfate
(equivalent to 3,5 mg neomycin base) 5,0 mg/ml.
The other ingredients are benzalkonium chloride 0,004 % m/v (as a
preservative), Liquifilm
®
(polyvinyl alcohol), disodium edetate, sodium
phosphate dibasic heptahydrate, sodium
chloride, sodium thiosulfate pentahydrate, polysorbate 80 (10 %
solution), purified water.
2. WHAT FML-NEO
™ IS USED FOR
FML-NEO™ is used for the treatment of conjunctivitis (sticky eyes)
due to organisms sensitive
to neomycin.
FML-NEO™ may be used for the treatment of infections at the front of
the eye by bacteria
sensitive to the antibiotic neomycin.
FML-NEO™ can be used following removal of something from your eye,
as well as before and
after surgery, where there is a possibility of infection with
susceptible organisms.
3. BEFORE YOU USE FML-NEO
™
DO NOT USE FML-NEO
™
:
AbbVie (Pty) Ltd
FML-NEO Liquifilm Ophthalmic Suspension
Fluorometholone 1,0 mg/ml
Neomycin sulphate equivalent to neomycin base 3,5 mg/ml
1.3.2 Patient Information Leaflet
Page 2 of 3

If you are hypersensitive (allergic) to fluorometholone or neomycin
sulfate or to any of
the
other
ingredients
of
FML-NE

Summary of Product characteristics

AbbVie (Pty) Ltd
FML-NEO Liquifilm Ophthalmic Suspension
Fluorometholone 1,0 mg/ml
Neomycin sulphate equivalent to neomycin base 3,5 mg/ml _ _
1.3.1.1 Professional Information
Page 1 of 3
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME AND DOSAGE FORM
FML-NEO Liquifilm Ophthalmic Suspension
COMPOSITION
FML-NEO Liquifilm Ophthalmic Suspension contains per ml:
Fluorometholone 1,0 mg
Neomycin sulfate (equivalent to 3,5 mg neomycin base) 5,0 mg
Excipients: Benzalkonium chloride 0,004 % m/v (as a preservative),
Liquifilm
®
(polyvinyl
alcohol), disodium edetate, sodium phosphate, dibasic, heptahydrate,
sodium chloride,
sodium thiosulfate, pentahydrate, polysorbate 80 (10% solution),
purified water
PHARMACOLOGICAL CLASSIFICATION
A. 15.2 Ophthalmic preparation with corticosteroids
PHARMACOLOGICAL ACTION
Fluorometholone is a glucocorticoid and has anti-inflammatory
properties. It inhibits the
inflammatory response (oedema, fibrin deposition, capillary dilation,
and phagocytic migration)
as well as capillary proliferation, deposition of collagen and scar
formation.
Glucocorticosteroids such as fluorometholone may increase intraocular
pressure, in normal
eyes and in subjects with ocular hypertension.
Neomycin is a broad spectrum bactericidal aminoglycoside antibiotic
with activity against
gram-positive
and
gram-negative
organisms.
Due
to
extensive
topical
use,
neomycin
resistance has been reported among _Pseudomonas aeruginosa_,
_Staphylococci_, and some
_Salmonella_,
_Shigella_,
and
_Escherichia _
_coli_
strains.
Cross-resistance
with
kanamycin,
framycetin and paromomycin occurs. The primary mechanism of action is
through inhibition of
protein synthesis by irreversibly binding with 30S ribosomal subunits.
Pus, exudates, and
bacteria growth products do not inactivate the antibiotic.
AbbVie (Pty) Ltd
FML-NEO Liquifilm Ophthalmic Suspension
Fluorometholone 1,0 mg/ml
Neomycin sulphate equivalent to neomycin base 3,5 mg/ml _ _
1.3.1.1 Professional Information
Page 2 of 3
INDICATIONS
FML-NEO is indicated in the treatment of infec