FML LIQUIFILM OPHTHALMIC SUSPENSION 0.1%

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

FLUOROMETHOLONE

Dostupné z:

ABBVIE PTE. LTD.

ATC kód:

S01BA07

Dávkovanie:

1 mg/ml

Forma lieku:

SOLUTION

Zloženie:

FLUOROMETHOLONE 1 mg/ml

Spôsob podávania:

OPHTHALMIC

Typ predpisu:

Prescription Only

Výrobca:

ALLERGAN PHARMACEUTICALS IRELAND

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

1990-05-03

Súhrn charakteristických

FML
®
(fluorometholone 0.1%)
LIQUIFILM
TM
Sterile Ophthalmic Suspension
EACH ML CONTAINS: fluorometholone 1 mg with: LIQUIFILM
TM
(polyvinyl alcohol) 14 mg,
benzalkonium chloride 0.04 mg, edetate disodium, sodium chloride,
sodium phosphate
monobasic, sodium phosphate dibasic, polysorbate 80, and purified
water.
ACTIONS
Inhibition of the inflammatory response to inciting agents of
mechanical, chemical or
immunological nature. No generally accepted explanation of this
steroid property has been
advanced. However, corticosteroids are thought to act by the induction
of phospholipase A
2
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by
inhibiting the release of their common precursor arachidonic acid.
Arachidonic acid is released
from membrane phospholipids by phospholipase A
2
. Adrenocorticosteroids and their derivatives
are capable of producing a rise in intraocular pressure. In clinical
studies on patients' eyes
treated with both dexamethasone and fluorometholone, fluorometholone
demonstrated a lower
propensity to increase intraocular pressure than did dexamethasone.
INDICATIONS
For steroid responsive inflammation of the palpebral and bulbar
conjunctiva, cornea and anterior
segment of the globe.
CONTRAINDICATIONS
Acute superficial (or epithelial) herpes simplex keratitis (dendritic
keratitis).
Fungal diseases of ocular structures.
Vaccinia, varicella and most other viral diseases of the cornea and
conjunctiva.
Mycobacterial infection such as tuberculosis of the eye.
Hypersensitivity to the constituents of
this medication.
WARNINGS
Employment of a corticosteroid medication in the treatment of patients
with a history of herpes
simplex requires great caution.
Prolonged use may cause increased intraocular pressure in susceptible
individuals resulting in
glaucoma and infrequent damage to the optic nerve, defects in visual
acuity and fields of vision;
posterior subcapsular cat