PIPERACILLIN AND TAZOBACTAM FOR INJECTION POWDER FOR SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)

Disponível em:

EUGIA PHARMA INC.

Código ATC:

J01CR05

DCI (Denominação Comum Internacional):

PIPERACILLIN AND BETA-LACTAMASE INHIBITOR

Dosagem:

2G; 0.25G

Forma farmacêutica:

POWDER FOR SOLUTION

Composição:

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

Via de administração:

INTRAVENOUS

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Resumo do produto:

Active ingredient group (AIG) number: 0225919001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2022-07-08

Características técnicas

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_PAGE 1 OF 42 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PIPERACILLIN AND TAZOBACTAM FOR INJECTION
Lyophilized Powder for Injection
2 g piperacillin (as piperacillin sodium) and 0.25 g tazobactam (as
tazobactam sodium) per vial
3 g piperacillin (as piperacillin sodium) and 0.375 g tazobactam (as
tazobactam sodium) per vial
4 g piperacillin (as piperacillin sodium) and 0.5 g tazobactam (as
tazobactam sodium) per vial
For Intravenous Use Only
Manufacturer's Standard
Antibiotic/β-lactamase Inhibitor
EUGIA PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario
L4L 8K8 Canada
Submission Control No.: 264640
DATE OF
PREPARATION:
July 8, 2022
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_PAGE 2 OF 42 _
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
..............................................................22
DOSAGE FORMS, COMP