Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland
Yellox is indicated in adults for the treatment of postoperative ocular inflammation following cataract extraction.
The dose is one drop of Yellox in the affected eye(s) twice daily, beginning the next day after cataract surgery and continuing through the first 2 weeks of the postoperative period.
The treatment should not exceed 2 weeks as safety data beyond this is not available.
Yellox has not been studied in patients with hepatic disease or renal impairment.
The safety and efficacy of bromfenac in paediatric patients has not been established. No data are available.
For ocular use.
If more than one topical ophtalmic medicinal product is being used, each one should be administered at least 5 minutes apart.
To prevent contamination of the dropper-tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper-tip of the bottle.
No abnormal findings or adverse reactions of clinical concern were noted upon administration of two drops 2mg/ml solution four times a day for the period of up to 28 days. Accidental administration of more than one drop should not result in increased topical exposure as excessive volume would rinse out of the eye due to limited conjunctival sac capacity.
There is practically no risk of adverse effects due to accidental oral ingestion. Ingestion of the 5 ml bottle content corresponds to an oral dose of less than 5 mg bromfenac, which is 30 times lower than daily dose of bromfenac oral formulation formerly used.
If Yellox is accidentally ingested, fluids should be taken to dilute the medicinal product.
2 years.
After first opening: 4 weeks.
Do not store above 25°C.
Patients should be instructed to keep the bottle tightly closed when not in use.
5 ml solution in a polyethylene squeeze bottle with a dropper-tip and a polyethylene screw cap.
Pack of 1 bottle.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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