Pays: Afrique du Sud
Langue: anglais
Source: South African Health Products Regulatory Authority (SAHPRA)
Alcon
MAXIDEX™ Ophthalmic suspension SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): MAXIDEX™ Ophthalmic suspension COMPOSITION: Each mL contains dexamethasone 1,0 mg. Preserved with benzalkonium chloride 0,01% (m/v). PHARMACOLOGICAL CLASSIFICATION: A 15.3 Combination antibiotics and/or sulphonamides and corticosteroids. PHARMACOLOGICAL ACTION: Dexamethasone is a 9-fluoro 16-methyl substituted hydrocortisone analog with an anti-inflammatory potency approximately 25 times that of hydrocortisone. Therapeutic concentrations are attained in the aqueous humor of the eye following application into the conjunctival sac. INDICATIONS: Ophthalmic: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. Otic: Steroid responsive inflammatory conditions of the external auditory meatus such as allergic otitis externa selected purulent and non-purulent infective otitis externa when in oedema and inflammation. CONTRA-INDICATIONS: Contra-indicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication. The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body. Topical corticosteroids should not be used in the treatment of mechanical lacerations and abrasions of the eye. They delay healing and promote the development and spread of infection. WARNINGS: Prolonged use may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision and posterior subcapsular cataract formation. If this product is used for 10 days or longer, intraocular pressure should b Lire le document complet