PIPERACILLIN AND TAZOBACTAM FOR INJECTION POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

J01CR05

INN (Διεθνής Όνομα):

PIPERACILLIN AND BETA-LACTAMASE INHIBITOR

Δοσολογία:

2G; 0.25G

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

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

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

10X2.25G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

EXTENDED-SPECTRUM PENICILLINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0225919004; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2021-10-22

Αρχείο Π.Χ.Π.

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