Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SOLUTION
**DOSAGE AND ADMINISTRATION** 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.
OPHTHALMIC
Medical Information
**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.
S01BA07
fluorometholone
Manufacturer Information
ABBVIE PTE. LTD.
ALLERGAN PHARMACEUTICALS IRELAND
Active Ingredients
Documents
Package Inserts
FML LIQUIFILM OPHTHALMIC SUSPENSION PI.pdf
Approved: September 20, 2018