Zerbaxa 1.5g powder for solution for injection

País: Malásia

Língua: inglês

Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes ativos:

TAZOBACTAM SODIUM; CEFTOLOZANE SULFATE

Disponível em:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

DCI (Denominação Comum Internacional):

TAZOBACTAM SODIUM; CEFTOLOZANE SULFATE

Unidades em pacote:

10vial Vials

Fabricado por:

Steri-Pharm, LLC

Folheto informativo - Bula

Not Applicable

Características técnicas

ZERBAXA
®
1.5g powder for solution for injection
LPC-MK7625A-IV-112018c
1
INDICATIONS AND USAGE
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.
1.1
Complicated Intra-abdominal Infections
ZERBAXA used in combination with metronidazole is indicated for the
treatment of complicated
intra-abdominal infections (cIAI) 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 constellatus,
and
Streptococcus salivarius
.
1.2
Complicated Urinary Tract Infections, Including Pyelonephritis
ZERBAXA is indicated for the treatment of complicated urinary tract
infections (cUTI), including
pyelonephritis, caused by the following Gram-negative microorganisms:
Escherichia coli
,
Klebsiella
pneumoniae
,
Proteus mirabilis
, and
Pseudomonas aeruginosa
.
1.3 Nosocomial Pneumonia, including Ventilator-associated Pneumonia
Treatment of nosocomial pneumonia, including ventilator-associated
pneumonia, caused by the
following susceptible Gram-negative microorganisms:
Enterobacter cloacae, Escherichia coli,
Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae,
Proteus mirabilis, Pseudomonas
aeruginosa,
and
Serratia marcescens.
1.4 Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ZERBAXA
and other antibacterial drugs, ZERBAXA should be used only to treat
infections that are proven
or
strongly suspected to be caused by susceptible bacteria. When culture
and susceptibility
information are
available, they should be considered in selecting or modifying
antibacterial
therapy. In the absence of
such data, local epidemiology and susceptibility patterns may
contribute to the empiric selection of
therapy.
2
DOSAGE AND ADMINISTRATION
2.1
Recommended Dosage