TAZOCIN

Land: Indonesien

Sprache: Indonesisch

Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Wirkstoff:

PIPERACILLIN; TAZOBACTAM

Verfügbar ab:

PFIZER INDONESIA - Indonesia

INN (Internationale Bezeichnung):

PIPERACILLIN; TAZOBACTAM

Dosierung:

4000/500 MG

Darreichungsform:

SERBUK INJEKSI LIOFILISASI

Einheiten im Paket:

DUS, 12 VIAL @ 4,5 G

Hergestellt von:

WYETH LEDERLE S.p.A - Italy

Berechtigungsdatum:

2016-05-13

Fachinformation

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,
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