ZERBAXA POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CEFTOLOZANE (CEFTOLOZANE SULFATE); TAZOBACTAM (TAZOBACTAM SODIUM)

Disponibil de la:

MERCK CANADA INC

Codul ATC:

J01DI54

INN (nume internaţional):

CEFTOLOZANE AND BETA-LACTAMASE INHIBITOR

Dozare:

1G; 0.5G

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

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

Calea de administrare:

INTRAVENOUS

Unități în pachet:

11.4ML (RECONST.) (1.5G)

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

THIRD GENERATION CEPHALOSPORINS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2015-09-30

Caracteristicilor produsului

_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