PIPERACILLIN AND TAZOBACTAM FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

J01CR05

INN (International Name):

PIPERACILLIN AND BETA-LACTAMASE INHIBITOR

Dosage:

36G; 4.5G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

PIPERACILLIN (PIPERACILLIN SODIUM) 36G; TAZOBACTAM (TAZOBACTAM SODIUM) 4.5G

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

EXTENDED-SPECTRUM PENICILLINS

Product summary:

Active ingredient group (AIG) number: 0225919008; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-07-07

Summary of Product characteristics

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_Piperacillin and Tazobactam for Injection _
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PRODUCT MONOGRAPH
INCUDING PATIENT MEDICATION INFORMATION
PR
PIPERACILLIN AND TAZOBACTAM FOR INJECTION
Piperacillin Sodium/Tazobactam Sodium
Lyophilized Powder for Injection
For Intravenous Use Only
MANUFACTURER’S STANDARD
PIPERACILLIN 12 G (AS PIPERACILLIN SODIUM) AND TAZOBACTAM 1.5 G (AS
TAZOBACTAM SODIUM) PER VIAL
PIPERACILLIN 36 G (AS PIPERACILLIN SODIUM) AND TAZOBACTAM 4.5 G (AS
TAZOBACTAM SODIUM) PER VIAL
Antibiotic/β-lactamase Inhibitor
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, Ontario
M9W 0C8
Date of Revision:
November 18, 2020
Submission Control No.: 246054
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_Piperacillin and Tazobactam for Injection _
_Page 2 of 43_
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
......................................................