YELLOX Eye drops, solution (2020)
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Περιεχόμενα
Name of the medicinal product
Yellox 0.9 mg/ml eye drops solution.
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 ...
Pharmaceutical form
Eye drops, solution. Clear yellow solution. pH: 8.1-8.5; osmolality: 270-330 mOsmol/kg
Therapeutic indications
Yellox is indicated in adults for the treatment of postoperative ocular inflammation following cataract extraction.
Posology and method of administration
Posology Use in adults, including the elderly 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 ...
Contraindications
Hypersensitivity to bromfenac or to any of the excipients listed in section 6.1, or to other non- steroidal anti-inflammatory medicinal products (NSAIDs). Yellox is contraindicated in patients in whom ...
Special warnings and precautions for use
All topical NSAIDs may slow or delay healing like topical corticosteroids. Concomitant use of NSAIDs and topical steroids may increase the potential for healing problems. Cross-sensitivity There is the ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. No interactions with antibiotic eye drops used in conjunction with surgery have been reported.
Pregnancy and lactation
Pregnancy There are no adequate data from the use of bromfenac in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Since ...
Effects on ability to drive and use machines
Yellox has minor influence on the ability to drive and use machines. Transient blurring of vision may occur on instillation. If blurred vision occurs at instillation patients should be advised to refrain ...
Undesirable effects
Summary of the safety profile Based on clinical data available, a total of 3.4% of patients experienced one or more adverse reactions. The most common or most important reactions in the pooled studies ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Ophtalmologicals, Antiinflammatory agents, non-steroids ATC code: S01BC11 Mechanism of action Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) that has anti-inflammatory ...
Pharmacokinetic properties
Absorption Bromfenac efficiently permeates the cornea of cataract patients: A single dose resulted in a mean peak aqueous humour concentrations of 79±68 ng/ml at 150-180 minutes after dosing. Concentrations ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated-dose toxicity, genotoxicity and carcinogenic potential. However, 0.9 mg/kg/day in rats ...
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)
Incompatibilities
Not applicable.
Shelf life
2 years. After first opening: 4 weeks.
Special precautions for storage
Do not store above 25°C. Patients should be instructed to keep the bottle tightly closed when not in use.
Nature and contents of container
5 ml solution in a polyethylene squeeze bottle with a dropper-tip and a polyethylene screw cap. Pack of 1 bottle.
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland
Marketing authorization number(s)
EU/1/11/692/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 18.05.2011 Date of latest renewal: 11.01.2016
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