Страна: Канада
Език: английски
Източник: Health Canada
SULFACETAMIDE SODIUM; PREDNISOLONE ACETATE
PHARMA STULLN INC.
S01CA02
PREDNISOLONE AND ANTIINFECTIVES
10%; 0.5%
SUSPENSION
SULFACETAMIDE SODIUM 10%; PREDNISOLONE ACETATE 0.5%
OPHTHALMIC
250ML
Prescription
SULFONAMIDES
Active ingredient group (AIG) number: 0206094002; AHFS:
APPROVED
2017-05-15
PRESCRIBING INFORMATION PR PREDNISOLONE/SULFACETAMIDE SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION, USP CORTICOSTEROID / ANTIBACTERIAL PHARMA STULLN INC. 6500 TransCanada Highway, Suite 400 Pointe-Claire, Québec H9R 0A5 SUBMISSION CONTROL NO.: 236530 DATE OF REVISION: April 16, 2020 2 PRESCRIBING INFORMATION PR PREDNISOLONE/SULFACETAMIDE SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION, USP CORTICOSTEROID / ANTIBACTERIAL ACTION AND CLINICAL PHARMACOLOGY Prednisolone acetate is a potent synthetic corticosteroid with anti-inflammatory properties, useful in the treatment of inflammatory conditions of the eye, particularly the anterior segment. Corticosteroids suppress the inflammatory response to a variety of agents. Since they may inhibit the body’s defense mechanism against infection. A concomitant antibacterial drug may be used when there is the risk of ocular infection. Corticosteroids probably also delay healing. Sulfacetamide sodium is a sulfonamide with bacteriostatic action, except at very high concentrations as may occur with ophthalmic use, when it may be bactericidal. It interferes with the utilization of para-aminobenzoic acid by bacteria, thus preventing the essential biosynthesis of folic acid, and inhibiting growth of a wide variety of gram- negative and gram-positive bacteria. It is particularly suited to the eye because it is freely soluble in water and less alkaline, and therefore less irritating to the eye, than other sulfonamides. NON-MEDICINAL INGREDIENTS Benzalkonium Chloride 0.025%, Disodium Edetate. Hydroxypropyl Methylcellulose, Polysorbate 80, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Sodium Thiosulphate and Purified Water. INDICATIONS For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or risk of bacterial infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe s Прочетете целия документ