País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
Doripenem monohydrate
CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED
500 mg
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Doripenem monohydrate 500 mg
INTRAVENOUS
Prescription Only
Shionogi Pharma Co., Ltd.
ACTIVE
2009-03-13
1 NAME OF THE MEDICINAL PRODUCT DORIBAX™ Powder for Injection 500mg QUALITATIVE AND QUANTITATIVE COMPOSITION DORIBAX™, doripenem monohydrate for injection vials contain 500 mg of doripenem on an anhydrous basis. All references to doripenem activity are expressed in terms of the active doripenem moiety. DORIBAX™ is not formulated with any inactive ingredients. PHARMACEUTICAL FORM DORIBAX™ vials contain 500 mg of doripenem, a white to slightly yellowish off-white crystalline powder. The powder is constituted for intravenous infusion. The pH of the infusion solution is between 4.5 and 5.5. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS DORIBAX™ is a carbapenem antibiotic indicated as a single agent for the treatment of the following infections caused by susceptible bacteria: (See _Microbiology._) • Complicated intra-abdominal infections • Complicated urinary tract infections, including complicated and uncomplicated pyelonephritis and cases with concurrent bacteremia_ _ Doribax is also indicated for the treatment of nosocomial pneumonia, including ventilator- associated pneumonia, caused by susceptible bacteria. In the nosocomial pneumonia clinical studies, adjunctive use of an aminoglycoside was permitted. _ _ Because of its broad spectrum of bactericidal activity against gram-positive and gram- negative aerobic and anaerobic bacteria, DORIBAX™ can be considered for treatment of complicated and mixed infections. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to doripenem. In the absence of such data, local epidemiology Leia o documento completo
1 NAME OF THE MEDICINAL PRODUCT DORIBAX™ Powder for Injection 500mg QUALITATIVE AND QUANTITATIVE COMPOSITION DORIBAX™, doripenem monohydrate for injection vials contain 500 mg of doripenem on an anhydrous basis. All references to doripenem activity are expressed in terms of the active doripenem moiety. DORIBAX™ is not formulated with any inactive ingredients. PHARMACEUTICAL FORM DORIBAX™ vials contain 500 mg of doripenem, a white to slightly yellowish off-white crystalline powder. The powder is constituted for intravenous infusion. The pH of the infusion solution is between 4.5 and 5.5. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS DORIBAX™ is a carbapenem antibiotic indicated as a single agent for the treatment of the following infections caused by susceptible bacteria: (See _Microbiology._ ) • Complicated intra-abdominal infections • Complicated urinary tract infections, including complicated and uncomplicated pyelonephritis and cases with concurrent bacteremia _ _ Doribax is also indicated for the treatment of nosocomial pneumonia, including ventilator- associated pneumonia, caused by susceptible bacteria. In the nosocomial pneumonia clinical studies, adjunctive use of an aminoglycoside was permitted. _ _ Because of its broad spectrum of bactericidal activity against gram-positive and gram- negative aerobic and anaerobic bacteria, DORIBAX™ can be considered for treatment of complicated and mixed infections. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to doripenem. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of DORIBAX™ is 500 mg administered every 8 hours by intravenous infusion. The recommended dosage and administration by infection is described in Table 1: 2 TABLE 1: DOSAGE OF DORIBAX™ BY INFECTION_ _ _INFECTION _ _DOSAGE _ _FREQUE Leia o documento completo