VPI-PIPERACILLIN AND TAZOBACTAM FOR INJECTION POWDER FOR SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)

Boleh didapati daripada:

VPI PHARMACEUTICALS INC

Kod ATC:

J01CR05

INN (Nama Antarabangsa):

PIPERACILLIN AND BETA-LACTAMASE INHIBITOR

Dos:

3G; 0.375G

Borang farmaseutikal:

POWDER FOR SOLUTION

Komposisi:

PIPERACILLIN (PIPERACILLIN SODIUM) 3G; TAZOBACTAM (TAZOBACTAM SODIUM) 0.375G

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

10 VIALS

Jenis preskripsi:

Prescription

Kawasan terapeutik:

EXTENDED-SPECTRUM PENICILLINS

Ringkasan produk:

Active ingredient group (AIG) number: 0225919005; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2016-02-29

Ciri produk

VPI-Piperacillin and Tazobactam for Injection
Page 1 of 45
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VPI-PIPERACILLIN AND TAZOBACTAM FOR
INJECTION
2.0g piperacillin (as piperacillin sodium) and 0.25g tazobactam (as
tazobactam sodium) per vial
3.0g piperacillin (as piperacillin sodium) and 0.375g tazobactam (as
tazobactam sodium) per vial
4.0g piperacillin (as piperacillin sodium) and 0.5g tazobactam (as
tazobactam sodium) per vial
12.0g piperacillin (as piperacillin sodium) and 1.5g tazobactam (as
tazobactam sodium) per vial
36.0g piperacillin (as piperacillin sodium) and 4.5g tazobactam (as
tazobactam sodium) per vial
Lyophilized Powder for Injection
USP
STERILE
For Intravenous Use Only
Antibiotic/ß-lactamase Inhibitor
VPI PHARMACEUTICALS INC.
16667 Hymus Blvd.
Kirkland, Quebec
H9H 4R9
Date of Revision:
May 22, 2018
Submission Control No: 211727
VPI-Piperacillin and Tazobactam for Injection
Page 2 of 45
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
OVERDOS