PIPERACILLIN AND TAZOBACTAM FOR INJECTION POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

J01CR05

INN (nume internaţional):

PIPERACILLIN AND BETA-LACTAMASE INHIBITOR

Dozare:

2G; 0.25G

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

PIPERACILLIN (PIPERACILLIN SODIUM) 2G; TAZOBACTAM (TAZOBACTAM SODIUM) 0.25G

Calea de administrare:

INTRAVENOUS

Unități în pachet:

10X2.25G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

EXTENDED-SPECTRUM PENICILLINS

Rezumat produs:

Active ingredient group (AIG) number: 0225919004; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-10-22

Caracteristicilor produsului

_Piperacillin and Tazobactam for Injection _
_Page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PIPERACILLIN AND TAZOBACTAM FOR INJECTION
piperacillin
sodium/tazobactam sodium
Lyophilized
Powder for Injection
For Intravenous Use Only
2 g / 0.25 g, 3 g / 0.375 g, 4 g / 0.5 g, 12 g / 1.5 g, 36 g / 4.5 g
per vial (as piperacillin sodium and as
tazobactam sodium)
Manufacturer’s Standard
Antibiotic
/ ß-lactamase Inhibitor
Sandoz Canada Inc.
110 Rue de Lauzon
Date of Revision:
October 18, 2021
Boucherville,
QC, Canada
J4B 1E6
Submission
Control No: 248976
_Piperacillin and Tazobactam for Injection _
_Page 2 of 47 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION............................................................3
SUMMARY PRODUCT INFORMATION
.................................................................................3
INDICATIONS AND CLINICAL
USE.......................................................................................3
CONTRAINDICATIONS
...........................................................................................................5
WARNINGS AND PRECAUTIONS
..........................................................................................5
ADVERSE REACTIONS
...........................................................................................................9
DRUG
INTERACTIONS..........................................................................................................
12
DOSAGE AND
ADMINISTRATION.......................................................................................
14
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
20
STORAGE AND
STABILITY..................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
..............................................