FLUCON Ophthalmic suspension Ref.[115320] Active ingredients: Fluorometholone

Source: Health Products Regulatory Authority (ZA)  Publisher: Novartis South Africa (Pty) Ltd, Magwa Crescent West, Waterfall City, Jukskei View, 2090

Product name and form

FLUCON ophthalmic suspension.

Pharmaceutical Form

White to off-white suspension.

Qualitative and quantitative composition

Each ml of the suspension contains: Fluorometholone 1 mg.

Preservative: Benzalkonium chloride 0,01%.

For the full list of excipients, see section 6.1.

Active Ingredient

Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It is a member of the group of universally known steroids used for the treatment of eye inflammation. Glucocorticosteroids bind to cytoplasmic receptors and control the synthesis of infection mediators thus damping inflammatory reactions (swelling, fibrin deposition, capillary dilatation, phagocyte migration) and also capillary proliferation, collagen deposition and scarring.
List of Excipients

Polyvinyl alcohol
Sodium chloride
Disodium phosphate anhydrous
Hypromellose
Polysorbate 80
Sodium dihydrogen phosphate monohydrate
Disodium edetate
Benzalkoinium chloride
Purified water

Pack sizes and marketing

Plastic dropper bottle containing 5 ml.

Marketing authorization holder

Novartis South Africa (Pty) Ltd, Magwa Crescent West, Waterfall City, Jukskei View, 2090

Marketing authorization dates and numbers

N/15.2/16

09/11/1981

Drugs

Drug Countries
FLUCON France, Poland, Tunisia, South Africa
 
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