ZERBAXA POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CEFTOLOZANE (CEFTOLOZANE SULFATE); TAZOBACTAM (TAZOBACTAM SODIUM)

Tersedia dari:

MERCK CANADA INC

Kode ATC:

J01DI54

INN (Nama Internasional):

CEFTOLOZANE AND BETA-LACTAMASE INHIBITOR

Dosis:

1G; 0.5G

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

CEFTOLOZANE (CEFTOLOZANE SULFATE) 1G; TAZOBACTAM (TAZOBACTAM SODIUM) 0.5G

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

11.4ML (RECONST.) (1.5G)

Jenis Resep:

Prescription

Area terapi:

THIRD GENERATION CEPHALOSPORINS

Ringkasan produk:

Active ingredient group (AIG) number: 0257450001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-09-30

Karakteristik produk

_ZERBAXA_
_®_
_ (ceftolozane and tazobactam) _
_Page 1 of 41_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ZERBAXA
®
Ceftolozane and Tazobactam powder for injection
1.5 gram (g) per vial
Containing ceftolozane 1 g (as ceftolozane sulfate) and tazobactam 0.5
g (as tazobactam sodium)
Cephalosporin and Beta-lactamase Inhibitor
antibacterial for systemic use
MERCK CANADA INC.
DATE OF PREPARATION:
16750 route Transcanadienne
October 7, 2020
Kirkland, QC
Canada H9H 4M7
www.merck.ca
SUBMISSION CONTROL NO: 238477
_ _
_ZERBAXA_
®
_ (ceftolozane and tazobactam) _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL