FML fluorometholone 1mg/mL eye drops bottle

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

fluorometholone, Quantity: 1 mg/mL

Beschikbaar vanaf:

Abbvie Pty Ltd

farmaceutische vorm:

Eye Drops, suspension

Samenstelling:

Excipient Ingredients: benzalkonium chloride; disodium edetate; sodium chloride; monobasic sodium phosphate; dibasic sodium phosphate heptahydrate; polysorbate 80; sodium hydroxide; purified water; polyvinyl alcohol

Toedieningsweg:

Ophthalmic

Eenheden in pakket:

5mL

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

INDICATIONS AS AT 23 OCT 1995 : For steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Product samenvatting:

Visual Identification: Milky suspension; Container Type: Bottle; Container Material: LDPE; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Restricted flow insert

Autorisatie-status:

Registered

Autorisatie datum:

1991-10-14

Bijsluiter

FML
®
fluorometholone Eye Drops CMI v5.0, PI v5.0 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 absorbed by an

Productkenmerken

FML
®
FLUOROMETHOLONE Product Information v 6.0; CCDS v4.0 and v5.0
Page
1 of 7
AUSTRALIAN PRODUCT INFORMATION
FML
®
(FLUOROMETHOLONE) EYE DROPS
1. NAME OF THE MEDICINE
FML
®
fluorometholone 1 mg/mL eye drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
FML
®
eye drops contain fluorometholone 1 mg/mL (0.1%).
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
A topical anti-inflammatory glucosteroid eye drop.
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 order to minimise systemic absorption of FML
®
eye drops, apply pressure to the tear duct
immediately following administration of the drug.
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 constituents of this medication.
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).
FML
®
FLUOROMETHOLONE Product Information v 6.0; CCDS v4.0 and v5.0 Page
2 of 7
Eye drops containing a corticosteroid should not be used for more than
10 days except under strict
ophthalmic supervision with regular checks for intraocular pressure.
Prolonged use may cause increased intraocular pressure in susceptible
individuals resulting in
gla