FML

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Fluorometholone 1 mg/mL;  

थमां उपलब्ध:

AbbVie Limited

INN (इंटरनेशनल नाम):

Fluorometholone 1 mg/mL

डोज़:

0.1% w/v

फार्मास्यूटिकल फॉर्म:

Eye drops, solution

रचना:

Active: Fluorometholone 1 mg/mL   Excipient: Benzalkonium chloride Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate Polysorbate 80 Polyvinyl alcohol Purified water Sodium chloride Sodium edetate Sodium hydroxide

पैकेज में यूनिट:

Bottle, dropper, 5 mL

वर्ग:

Prescription

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

Sanofi Chimie

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Bottle, dropper, - 5 mL - 21 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

प्राधिकरण की तारीख:

1972-04-06

सूचना पत्रक

FML
®
fluorometholone Eye Drops CMI v7.0, PI v7.08 May 2023
Page 1 of 3
FML
®
EYE DROPS
_ _
[fluorometholone 1 mg/mL]
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about FML
®
eye drops, (including how to use
the eye drops). It does not
contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
FML
®
eye drops against the
benefits they expect it will have
for you.
If you have any concerns about
using/taking this medicine, ask
your doctor or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT
FML
®
EYE DROPS ARE
USED FOR
FML
®
eye drops are used for the
treatment of pain, swelling and
redness of the eye (inflammation).
The active ingredient in FML
®
eye drops, fluorometholone, acts
by inhibiting the inflammation
caused by certain irritations in the
eye.
FML
®
eye drops are only available
with a doctor’s prescription from
pharmacies.
Your doctor may have prescribed
FML
®
eye drops for another
reason. Ask your doctor if you
have any questions about why
FML
®
eye drops have been
prescribed for you.
BEFORE YOU USE
FML
®
EYE
DROPS
_WHEN YOU MUST NOT USE IT _
Do not use FML
®
eye drops if:
•
you are suffering from certain
medical conditions such as
herpes simplex keratitis
•
you have an eye infection
caused by fungi or viruses
•
you have an allergy to FML
®
eye drops or any of the
ingredients listed at the end of
this leaflet
•
you have tuberculosis of the
eye
•
the seal around the cap is
broken
•
the bottle/packaging shows
signs of tampering
•
the product does not look
quite right.
•
the expiry date on the bottle
or carton has passed
If you use this medicine after the
expiry date has passed, it may not
work effectively.
Do not put the eye drops into your
eye(s) while you are wearing soft
contact lenses. The preservative
in FML
®
eye drops (benzalkonium
chloride) may be abso

उत्पाद विशेषताएं

FML DS v 8.0
CCDS v 7.0
04 March 2024
Page 1 of 6
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
FML
®
0.1% w/v eye drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluorometholone 1 mg/mL (0.1% w/v)
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
A topical anti-inflammatory glucosteroid ophthalmic suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For steroid responsive inflammation of the palpebral and bulbar
conjunctiva, cornea and
anterior segment of the globe.
4.2 DOSE AND METHOD OF ADMINISTRATION
Bottle should be shaken before use.
1 to 2 drops instilled into the conjunctival sac two to four times
daily. During the initial 24 to
48 hours, the dosage may be safely increased to 2 drops every hour.
Care should be taken not
to discontinue therapy prematurely. In chronic conditions, withdrawal
of treatment should be
carried out by gradually decreasing the frequency of applications.
In order to minimise systemic absorption of FML
®
eye drops, apply pressure to the tear duct
immediately following administration of the drug.
_USE IN CHILDREN:_
Safety and effectiveness have not been demonstrated in children under
2 years of age.
4.3 CONTRAINDICATIONS
FML
®
is contraindicated in patients with:
•
acute superficial (or epithelial) _Herpes simplex_ keratitis
(dendritic keratitis),
•
fungal diseases of ocular structures,
•
vaccinia, varicella, mycobacterial infection of the eye and most other
viral diseases of
the cornea and conjunctiva,
•
tuberculosis of the eye,
•
hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
FML DS v 8.0
CCDS v 7.0
04 March 2024
Page 2 of 6
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Steroid medication in the treatment of patients with a history of
_Herpes simplex _keratitis
requires great caution. Frequent slit lamp microscopy is mandatory
(see Contraindications).
Eye drops containing a corticosteroid should not be used for more than
10 days except under
strict opthalmic supervision with regular checks for intr