מדינה: דרום אפריקה
שפה: אנגלית
מקור: South African Health Products Regulatory Authority (SAHPRA)
Alcon
TOBREX® ophthalmic solution TOBREX® ophthalmic ointment 34354-1 SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): TOBREX ® ophthalmic solution TOBREX ® ophthalmic ointment COMPOSITION: TOBREX ® ophthalmic solution: A sterile ophthalmic solution containing 3 mg tobramycin base per mL, preserved with 0,01% (m/v) benzalkonium chloride. TOBREX ® ophthalmic ointment: A sterile ophthalmic ointment containing 3 mg tobramycin base per g preserved with chlorobutanol 0,5% (m/m). PHARMACOLOGICAL CLASSIFICATION: A.15.1. Ophthalmic preparations with antibiotics and/or sulphonamides. PHARMACOLOGICAL ACTION: Tobramycin is a basic water-soluble aminoglycoside antibiotic with a spectrum of activity similar to that of gentamicin. It is active in vitro against Staph. aureus, most of the family Enterobacteriaceae, and Pseud. aeruginosa. Most staphylococci are inhibited by 1 ug/mL or less; most gram-negative bacteria by 2 ug/mL or less; and Pseudomonas, by 5 to 10 ug/mL or less. About 70% of Klebsiella and Enterobacter (aerobacter) are suppressed by 0,75 ug/mL and over 50% of E. Coli and indole-positive and-negative Proteus are inhibited by at least 3 ug/mL. Tobramycin is bactericidal for susceptible microbial species. It is less active in vitro than gentamicin for most gram negative bacteria but at least two to four times more active against Pseudomonas. There is evidence of transmissible resistance, although some organisms, especially staphylococci, may be resistant to other aminoglycosides and sensitive to tobramycin. INDICATIONS: TOBREX is a topical antibiotic indicated in the treatment of external bacterial infections of the eye and its adnexa caused by susceptible organisms. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany t קרא את המסמך השלם