LOTEMAX Eye-drops, suspension (2017)
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Περιεχόμενα
Name of the medicinal product
Lotemax 0.5% w/v Eye Drops, Suspension.
Qualitative and quantitative composition
The suspension contains 0.5%w/v loteprednol etabonate (5 mg/ml). Each drop contains 0.19 mg loteprednol etabonate. Excipient with known effect: Benzalkonium Chloride (0.01%). For the full list of excipients, ...
Pharmaceutical form
Eye-drops, suspension. Milky-white.
Therapeutic indications
Treatment of post-operative inflammation following ocular surgery.
Posology and method of administration
Posology Adults and elderly One to two drops four times daily beginning 24 hours after surgery and continuing throughout the post-operative period. The duration of treatment should not exceed 2 weeks. ...
Contraindications
Lotemax is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection ...
Special warnings and precautions for use
Prolonged use of corticosteroids may result in ocular hypertension or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. ...
Interaction with other medicinal products and other forms of interaction
Since loteprednol etabonate is not detected in plasma following the topical administration of Lotemax, it is not expected to affect the pharmacokinetics of systemically administered medicinal products. ...
Pregnancy and lactation
Pregnancy For Lotemax no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown and Lotemax ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. If there are any transient effects on vision, the patient should be advised to wait until these subside before driving ...
Undesirable effects
Reactions associated with ophthalmic steroids include elevated intraocular pressure in steroid responsive patients, which may be associated with optic nerve damage, visual acuity and field defects, posterior ...
Overdose
No case of overdose has been reported. Acute overdosage is unlikely to occur via the ophthalmic route.
Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroid ATC code: S01BA14 Mechanism of action Corticosteroids suppress the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No ...
Pharmacokinetic properties
Results from oral and ocular administration of Lotemax in normal volunteers have shown that there are low or undetectable concentrations of either unchanged material or the metabolite. Results from a bioavailability ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and genotoxicity. Embryotoxicity and teratogenic effects were observed in reproductive toxicity ...
List of excipients
Disodium edetate Glycerol Povidone Purified water Tyloxapol Hydrochloric acid (pH adjuster) Sodium hydroxide (pH adjuster) Benzalkonium chloride
Incompatibilities
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 2,5 mL: 15 months (unopened). 5 mL, 10 mL: 2 years (unopened). Discard any unused contents 28 days after first opening the bottle.
Special precautions for storage
Do not store above 25°C. Do not freeze. Store the container in an upright position.
Nature and contents of container
Lotemax is available in the following packaging configurations: 2.5 mL and 5 mL supplied in a white low density polyethylene bottle (7.5 mL) with a white control drop tip and a pink polypropylene cap. ...
Special precautions for disposal and other handling
Store the container in an upright position.
Marketing authorization holder
Bausch & Lomb GmbH, Brunsbütteler Damm 165-173, 13581, Berlin, Germany
Marketing authorization number(s)
PL 17947/0001
Date of first authorization / renewal of the authorization
31/03/2008
Date of revision of the text
October 2017
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