Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CEFOPERAZONE SODIUM; SULBACTAM SODIUM
PFIZER (MALAYSIA) SDN. BHD.
CEFOPERAZONE SODIUM; SULBACTAM SODIUM
2gm0 mcg/mL; 2 gm mcg/mL
Haupt Pharma Latina S.r.l.
Pfizer Confidential 1. NAME OF THE MEDICINAL PRODUCT SULPERAZON 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sulbactam sodium/cefoperazone sodium combination is available as a dry powder for reconstitution in a 1:1 ratio in terms of free SBT/CPZ. Sulbactam sodium is a derivative of the basic penicillin nucleus. It is an irreversible beta -lactamase inhibitor for parenteral use only. Chemically it is sodium penicillinate sulfone. It contains 92 mg sodium (4 mEq) per gram. Sulbactam is an off -white crystalline powder which is highly soluble in water. The molecular weight is 255.22. Cefoperazone sodium is a semisynthetic broad -spectrum cephalosporin antibiotic for parenteral use only. It contains 34 mg sodium (1.5 mEq) per gram. Cefoperazone is a white crystalline powder which is freely soluble in water. The molecular weight is 667.65. 3. PHARMACEUTICAL FORM Vials of the 1:1 product contain the equivalent of 500 mg + 500 mg and 1000 mg + 1000 mg of sulbactam and cefoperazone, respectively. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Monotherapy Sulbactam/cefoperazone is indicated for the treatment of the following infections when caused by susceptible organisms: 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 Read the complete document