PIPERACILLIN / TAZOBACTAM POWDER FOR INJECTION POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

J01CR05

DCI (Dénomination commune internationale):

PIPERACILLIN AND BETA-LACTAMASE INHIBITOR

Dosage:

3G; 0.375G

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

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

Mode d'administration:

INTRAVENOUS

Unités en paquet:

15ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

EXTENDED-SPECTRUM PENICILLINS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2011-10-26

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PIPERACILLIN/TAZOBACTAM POWDER FOR INJECTION
piperacillin sodium/tazobactam sodium
Lyophilized Powder for
Injection
For Intravenous Use Only
2g/0.25g, 3g/0.375g, 4g/0.5g per vial (as piperacillin sodium and as
tazobactam sodium)
USP
Antibiotic/ß-lactamase
Inhibito
r
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 190322
Date of Revision:
March 29, 2018
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
OVERDOSAGE
.............................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
18
STORAGE AND STABILITY
......................................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................