Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PIPERACILLIN, TAZOBACTAM
PFIZER INDONESIA - Indonesia
PIPERACILLIN, TAZOBACTAM
4000 MG /500 MG
SERBUK INJEKSI LIOFILISASI
DUS, 12 VIAL @ 4,5 G
WYETH LEDERLE S.R.L - Italy
2021-05-26
Generic Name: Sterile Piperacillin/Tazobactam Sodium Trade Name: TAZOCIN ® CDS Effective Date: September 13, 2021 Supersedes: March 26, 2019 Approved by BPOM: 2021-0070872 Page 1 of 17 PT PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Sterile Piperacillin/Tazobactam Sodium Trade Name: TAZOCIN ® CDS Effective Date: September 13, 2021 Supersedes: March 26, 2019 0 B PRESENTATION TAZOCIN, piperacillin/tazobactam parenteral combination, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Each TAZOCIN 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 g of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. The product also contains 1 mg edetate disodium (dihydrate) (EDTA) per vial. 1 B INDICATIONS AND USAGE TAZOCIN is indicated for the treatment of patients with moderate to severe infections caused by piperacillin resistant, piperacillin/tazobactam susceptible, _β-_lactamase producing strains of the designated microorganisms in the specified conditions listed below: Appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin resistant, _β-_lactamase producing strains of _Escherichia coli _or the following members of the _Bacteroides fragilis _group: _B. fragilis, B. ovatus, B. thetaiotaomicron _or _B. vulgatus_. The individual members of this group were studied in less than 10 cases. Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses, and ischemic/diabetic foot infections caused by piperacillin resistant, _β-_lactamase producing strains of _Staphylococcus aureus_. Postpartum endometritis or pelvic inflammatory disease caused by piperacillin resistant, _β-_lactamase producing strains of _Escherichia coli_. Community-acquired pneumonia (moderate severity only) caused by piperacillin resistant, _ Lue koko asiakirja