Active ingredients: Bromfenac
Yellox 0.9 mg/ml eye drops solution.
Eye drops, solution.
Clear yellow solution.
pH: 8.1-8.5; osmolality: 270-330 mOsmol/kg
1 ml of solution contains 0.9 mg bromfenac (as sodium sesquihydrate).
One drop contains approximately 33 micrograms bromfenac.
Excipient(s) with known effect: Each ml of solution contains 50 micrograms of benzalkonium chloride.
For the full list of excipients, see section 6.1.
Bromfenac is a topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. It is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. The most commonly reported adverse reactions in 3 to 8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia and vision blurred.
Boric acid
Borax
Sodium sulphite, anhydrous (E221)
Tyloxapol
Povidone (K30)
Benzalkonium chloride
Disodium edetate
Water for injections
Sodium hydroxide (for pH adjustment)
5 ml solution in a polyethylene squeeze bottle with a dropper-tip and a polyethylene screw cap.
Pack of 1 bottle.
Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland
EU/1/11/692/001
Date of first authorisation: 18.05.2011
Date of latest renewal: 11.01.2016