Država: Singapur
Jezik: engleski
Izvor: HSA (Health Sciences Authority)
AMPICILLIN SODIUM EQV AMPICILLIN; SULBACTAM SODIUM EQV SULBACTAM
PFIZER PRIVATE LIMITED
J01CR01
2 g/vial
INJECTION, POWDER, FOR SOLUTION
AMPICILLIN SODIUM EQV AMPICILLIN 2 g/vial; SULBACTAM SODIUM EQV SULBACTAM 1 g/vial
INTRAVENOUS, INTRAMUSCULAR
Prescription Only
Haupt Pharma Latina S.r.L
ACTIVE
1988-06-23
PFIZER UNASYN (Sulbactam Sodium/Ampicillin Sodium) For Intravenous or Intramuscular Use 1.0 NAME OF THE MEDICINAL PRODUCT UNASYN IM/IV 2.0 QUALITATIVE AND QUANTITATIVE COMPOSITION Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically it is sodium penicillanate sulfone and is an off-white crystalline powder highly soluble in water. The molecular weight is 255.22. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is D(-)- -aminobenzyl penicillin sodium salt and has a molecular weight of 371.39. Sulbactam sodium/ampicillin sodium IM/IV contains sulbactam sodium and ampicillin sodium in a 1:2 ratio. 3.0 PHARMACEUTICAL FORM Sulbactam sodium/ampicillin sodium IM/IV combination is available as a dry powder for reconstitution in vials containing the equivalent of 1,000 mg + 2,000 mg, 500 mg + 1,000 mg, 250 mg + 500 mg of sulbactam and ampicillin, respectively. 4.0 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sulbactam sodium/ampicillin sodium IM/IV is indicated for infections caused by susceptible microorganisms. Typical indications are upper and lower respiratory tract infections including sinusitis, otitis media and epiglottitis; bacterial pneumonias; urinary tract infections and pyelonephritis; intra-abdominal infections including peritonitis, cholecystitis, endometritis and pelvic cellulitis; bacterial septicemia; skin, soft tissue, bone and joint infections and gonococcal infections. Sulbactam sodium/ampicillin sodium IM/IV may also be administered peri-operatively to reduce the incidence of post-operative wound infections in patients undergoing abdominal or pelvic surgery, in which peritoneal contamination may be present. In termination of pregnancy or cesarean section, sulbactam sodium/ampicillin sodium IM/IV may be used prophylactically to reduce post-operative sepsis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sulbactam sodium/ampicillin sodium IM/IV can be administered by either intravenous or intramuscular routes. The following dilu Pročitajte cijeli dokument