FLAREX Sterile Ophthalmic Suspension Bottle

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

fluorometholone acetate, Quantity: 1 mg/mL

Mevcut itibaren:

Novartis Pharmaceuticals Australia Pty Ltd

Farmasötik formu:

Eye Drops, suspension

Kompozisyon:

Excipient Ingredients: sodium chloride; tyloxapol; benzalkonium chloride; monobasic sodium phosphate; hyetellose; purified water; hydrochloric acid; sodium hydroxide; disodium edetate

Uygulama yolu:

Ophthalmic

Paketteki üniteler:

5mL, 10mL

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

INDICATIONS AS AT 21 April 1989: Flurometholone Acetate Ophalmic Suspension is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

Ürün özeti:

Visual Identification: White to off- white solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

1991-10-15

Bilgilendirme broşürü

FLAREX™ EYE DROPS 0.1%
1
FLAREX™ EYE DROPS
0.1%
_Fluorometholone acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU USE FLAREX EYE
DROPS.
This leaflet answers some common
questions about Flarex. It does not
contain all of 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.NOVARTIS.COM.AU.
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 expected benefits of you using
FLAREX against the risks this
medicine could have for you.
If you have any concerns about using
this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT FLAREX IS USED
FOR
FLAREX Eye Drops are used to treat
the redness, swelling and other
symptoms of eye inflammation.
FLAREX Eye Drops contain the
active ingredient fluorometholone
acetate. Fluorometholone belongs to
a class of medicines known as
"steroids" or "corticosteroids" which
reduce inflammation.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
_USE IN CHILDREN _
This medicine is not recommended in
children.
The safety and effectiveness of
FLAREX Eye Drops has not been
established in children.
BEFORE YOU USE
FLAREX
_WHEN YOU MUST NOT USE IT _
Do not use this medicine if you have
an allergy to:

Fluorometholone

Any other similar medicines
containing other types of
"steroids"

Any of the ingredients

Ürün özellikleri

1
AUSTRALIAN PRODUCT INFORMATION – FLAREX
(FLUOROMETHOLONE ACETATE) EYE DROPS SUSPENSION
1
NAME OF THE MEDICINE
Fluorometholone acetate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in FLAREX EYE DROPS is fluorometholone acetate 1
mg/mL (0.1%).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, suspension. It is a sterile ophthalmic suspension.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Fluorometholone Acetate Ophthalmic Suspension is indicated for use in
the treatment of steroid
responsive inflammatory conditions of the palpebral and bulbar
conjunctiva, cornea and anterior
segment of the eye.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Shake well before use.
One to two 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 two drops every two
hours. Care should be taken
not to discontinue therapy prematurely.
4.3
C
ONTRAINDICATIONS
−
Mycobacterial ocular infections
−
Herpes simplex keratitis
−
Vaccinia, varicella and most other viral diseases of the cornea and
conjunctiva
−
Tuberculosis of the eye
−
Fungal diseases of ocular structures
−
Acute untreated infections
−
Hypersensitivity to the constituents of this medication.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
Employment of steroid medication in the treatment of stromal keratitis
or uveitis caused by herpes
simplex requires great caution; periodic slit lamp microscopy is
essential. Prolonged use may result
in ocular hypertension and/or glaucoma, damage to the optic nerve,
defects in visual acuity and
2
visual field, posterior subcapsular cataract formation and/or may aid
in the establishment of
secondary ocular infections from pathogens due to suppression of host
responses.
Acute infections of the eye may be masked or exacerbated by the
presence of steroid medications.
In those diseases causing thinning of the cornea or sclera,
perforation has been known to occ