PIPERACILLIN AND TAZOBACTAM FOR INJECTION POWDER FOR SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)

Доступно од:

SANDOZ CANADA INCORPORATED

АТЦ код:

J01CR05

INN (Међународно име):

PIPERACILLIN AND BETA-LACTAMASE INHIBITOR

Дозирање:

4G; 0.5G

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

PIPERACILLIN (PIPERACILLIN SODIUM) 4G; TAZOBACTAM (TAZOBACTAM SODIUM) 0.5G

Пут администрације:

INTRAVENOUS

Јединице у пакету:

10X4.5G

Тип рецептора:

Prescription

Терапеутска област:

EXTENDED-SPECTRUM PENICILLINS

Резиме производа:

Active ingredient group (AIG) number: 0225919006; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2021-10-22

Карактеристике производа

_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
..............................................