Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SULBACTAM SODIUM; Sterile Cefoperazone Sodium
KOTRA PHARMA (M) SDN. BHD.
SULBACTAM SODIUM; Sterile Cefoperazone Sodium
1 gm mcg/mL; 1 gm mcg/mL
KOTRA PHARMA (M) SDN. BHD.
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CEFOBACTAM 1G INJECTION COMPOSITION: Each vial contains Cefoperazone Sodium / Sulbactam Sodium equivalent to Cefoperazone 500mg and Sulbactam 500mg. PRESENTATION: White or off-white powder free from visible contamination. Clear to pale yellow solution after reconstitution. INDICATIONS: _Monotherapy:_ Sulbactam / cefoperazone is indicated for the treatment of the following infections when caused by susceptible organism: Respiratory tract infections (upper and lower). Urinary tract infections (upper and lower). Peritonitis. Cholecystitis. Cholangitis and other intra-abdominal infections. Septicemia. Meningitis. Skin and soft tissue infections. Bone and joint infections. Pelvic Inflammatory Disease. Endometritis. Gonorrhea and other infections of the genital tract. _Combination Therapy:_ Because of the broad spectrum of the activity of sulbactam/cefoperazone, most infections can be treated adequately with this antibiotic alone. However, sulbactam / cefoperazone may be used concomitantly with other antibiotics if such combinations are indicated. If an aminoglycoside is used (see Interaction With Other Medicaments), renal function should be monitored during the course of therapy (see Recommended Dose Use in Renal Function). PHARMACODYNAMICS: The antibacterial component of sulbactam / cefoperazone is cefoperazone, a third generation cephalosporin, which acts against sensitive organisms during the stage of active multiplication by inhibiting biosynthesis of cell wall mucopeptide. Sulbactam does not possess any useful antibacterial activity, except against Neisseriaceae and Acinetobacter. However, biochemical studies with cell-free bacterial systems have shown it to be an irreversible inhibitor of most important b - lactamases produced by b-lactam antibiotic - resistant organisms. The potential for sulbactam preventing the destruction of penicillins and cephalosporins by resistant organisms was confirmed in whole-organism studies using resistant strains in which sulbactam exhibited marked synergy with penicillins and cep Прочетете целия документ