ZERBAXA

Land: Indonesia

Språk: indonesisk

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

Aktiv ingrediens:

TAZOBACTAM SODIUM, CEFTOLOZANE SULFATE

Tilgjengelig fra:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (International Name):

TAZOBACTAM SODIUM, CEFTOLOZANE SULFATE

Dosering :

537 MG /1147 MG

Legemiddelform:

SERBUK INFUS

Enheter i pakken:

DUS, 10 VIAL @ 1.5 G

Produsert av:

Steri-Pharma LLC - United States of America

Autorisasjon dato:

2021-08-05

Preparatomtale

ZERBAXA™ (CEFTOLOZANE AND TAZOBACTAM)
POWDER FOR INFUSION
ZERBAXA (ceftolozane and tazobactam) for injection is indicated for
the treatment of patients
18 years or older with the following infections caused by designated
susceptible microorganisms:
COMPLICATED INTRA-ABDOMINAL INFECTIONS
ZERBAXA used in combination with metronidazole is indicated for the
treatment of patients with
complicated intra-abdominal infections (cIAI) and required surgical
intervention (e.g., laparotomy,
laparoscopic surgery, or percutaneous draining of an abscess) within
24 hours of (before or after)
the first dose of Zerbaxa. These cIAI are caused by the following
Gram-negative and Gram-positive
microorganisms:
Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella
pneumoniae,
Proteus
mirabilis,
Pseudomonas
aeruginosa,
Bacteroides
fragilis,
Streptococcus
anginosus,
Streptococcus constellatu
s, and
Streptococcus salivarius
.
COMPLICATED URINARY TRACT INFECTIONS, INCLUDING PYELONEPHRITIS
ZERBAXA is indicated for the treatment of patients with complicated
urinary tract infections (cUTI)
and pyuria with at least one of the following new or worsening
symptoms (dysuria, frequency,
suprapubic pain, urgency) and at least one of the following
complicating factors (current bladder
instrumentation, obstructive uropathy, urogenital surgery, functional
or anatomical abnormality of
the urogenital tract), including pyelonephritis, with or without
concurrent bacteremia, caused by the
following Gram-negative microorganisms:
Escherichia coli
,
Klebsiella pneumoniae
,
Proteus mirabilis
,
and
Pseudomonas aeruginosa
.
HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA OR VENTILATOR-ASSOCIATED
BACTERIAL PNEUMONIA (HABP /
VABP)
ZERBAXA is indicated for the treatment of patients 18 years and older
with hospital-acquired
bacterial
pneumonia
or
ventilator-associated
bacterial
pneumonia
caused
by
the
following
susceptible Gram-negative microorganisms:
Enterobacter cloacae, Escherichia coli, Haemophilus
influenza, Klebsiella oxytoca, Klebsiella pneumoniae, Pro