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YELLOX Eye drops, solution (2020)

Active ingredients: Bromfenac

Product Name and Form

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

Qualitative and Quantitative Composition

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.

Chemical substance
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
Borax
Sodium sulphite, anhydrous (E221)
Tyloxapol
Povidone (K30)
Benzalkonium chloride
Disodium edetate
Water for injections
Sodium hydroxide (for pH adjustment)

Pack sizes and Marketing

5 ml solution in a polyethylene squeeze bottle with a dropper-tip and a polyethylene screw cap.

Pack of 1 bottle.

Marketing authorization holder
Authorization dates

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Date of first authorisation: 18.05.2011
Date of latest renewal: 11.01.2016

Marketing authorization number:

EU/1/11/692/001