VEXOL Eye drops, suspension (2005)
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Περιεχόμενα
Name of the medicinal product
VEXOL 1% (10 mg/ml) eye drops, suspension.
Qualitative and quantitative composition
Rimexolone 10 mg/ml. For excipients, see section 6.1.
Pharmaceutical form
Eye drops, suspension. Vexol is a white to off-white suspension.
Therapeutic indications
VEXOL is indicated for the treatment of postoperative inflammation following ocular surgery, for the treatment of anterior uveitis, and for the treatment of corticosteroid responsive inflammation of the ...
Posology and method of administration
Postoperative Inflammation Apply one drop of VEXOL into the conjunctival sac of the affected eye four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative ...
Contraindications
Hypersensitivity to the active substance or any of the excipients. VEXOL is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and most other viral diseases ...
Special warnings and precautions for use
In more serious cases, and if the posterior part of the globe is affected, subconjunctival injection or treatment is recommended. But Vexol is not for injection. Prolonged use may result in ocular hypertension/glaucoma, ...
Interaction with other medicinal products and other forms of interaction
Specific drug interaction studies have not been conducted with VEXOL. No drug interactions were identified during the clinical development program. If concomitant eye preparations are to be used, the patient ...
Pregnancy and lactation
Pregnancy There are no adequate data from the use of Rimexolone in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Vexol ...
Effects on ability to drive and use machines
Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision or visual disturbances occur, the patient must wait until the vision clears before ...
Undesirable effects
In clinical studies with Vexol, the most frequently reported adverse events and local symptoms were: blurred vision (2.6%) and ocular discharge (2.2%). The following undesirable effects were reported during ...
Overdose
A topical overdose is not likely to be associated with toxicity. A topical overdosage of VEXOL may be flushed from the eye(s) with luke warm tap water. Accidental oral ingestion is also unlikely to be ...
Pharmacodynamic properties
*Pharmacotherapeutic Group: Ophthalmological anti-inflammatory corticosteroid SO1BA13 Corticosteroids suppress the inflammatory response to a variety of inciting agents of a mechanical, chemical, or immunological ...
Pharmacokinetic properties
As with other topically administered drugs, VEXOL is absorbed systemically. Studies in normal volunteers dosed bilaterally once every hour during waking hours for one week have demonstrated maximal serum ...
Preclinical safety data
Carcinogenesis, mutagenesis, impairment of fertility: Rimexolone has been shown to be not mutagenic in a battery of in vitro and in vivo mutagenicity assays. Fertility and reproductive capability was not ...
List of excipients
Benzalkonium chloride Mannitol Carbomer Polysorbate 80 Sodium chloride Disodium edetate Sodium hydroxide and/or hydrochloric acid Purified water
Incompatibilities
Not applicable.
Shelf life
1 year for the 3 mL bottle. 2 years for the 5 mL and 10 mL bottles. In use shelf life one month after first opening.
Special precautions for storage
Do not store above 30°C. Do not freeze.
Nature and contents of container
Low density polyethylene bottles (droptainer) containing 3 mL, 5 mL, or 10 mL and with polypropylene screw caps. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Alcon Laboratories (UK) Limited, Pentagon Park, Boundary Way Hemel Hempstead, Hertfordshire, HP2 7UD, United Kingdom
Marketing authorization number(s)
PL 00649/0136
Date of first authorization / renewal of the authorization
19 July 1995/19<sup>th</sup> July 2000 (to be amended to 19<sup>th</sup> July 2005 on approval of MRP renewal application)
Date of revision of the text
June 2005
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