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:

STERIMAX INC

Φαρμακολογική κατηγορία (ATC):

J01CR05

INN (Διεθνής Όνομα):

PIPERACILLIN AND BETA-LACTAMASE INHIBITOR

Δοσολογία:

36G; 4.5G

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

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

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

40.5G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

EXTENDED-SPECTRUM PENICILLINS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2015-03-25

Αρχείο Π.Χ.Π.

_ _
_Piperacillin and Tazobactam for Injection _
_Page 1 of 47_
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 2 G (AS PIPERACILLIN SODIUM) AND TAZOBACTAM 0.25 G (AS
TAZOBACTAM SODIUM) PER VIAL
PIPERACILLIN 3 G (AS PIPERACILLIN SODIUM) AND TAZOBACTAM 0.375 G (AS
TAZOBACTAM SODIUM) PER VIAL
PIPERACILLIN 4 G (AS PIPERACILLIN SODIUM) AND TAZOBACTAM 0.5 G (AS
TAZOBACTAM SODIUM) PER VIAL
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/ß-lactamase Inhibitor
SteriMax Inc.
2770 Portland Drive
Oakville, ON L6H 6R4
Date of Revision:
May 10, 2018
Submission Control No: 191213
_ _
_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
..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
.....