Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland
Yellox 0.9 mg/ml eye drops solution.
| Pharmaceutical Form |
|---|
|
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.
| Active Ingredient | Description | |
|---|---|---|
| Bromfenac |
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. |
| List of Excipients |
|---|
|
Boric acid |
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
| Drug | Countries | |
|---|---|---|
| YELLOX | Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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