PIPERACILLIN AND TAZOBACTAM FOR INJECTION POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
27-05-2022

유효 성분:

PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)

제공처:

HIKMA CANADA LIMITED

ATC 코드:

J01CR05

INN (국제 이름):

PIPERACILLIN AND BETA-LACTAMASE INHIBITOR

복용량:

2G; 0.25G

약제 형태:

POWDER FOR SOLUTION

구성:

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

관리 경로:

INTRAVENOUS

패키지 단위:

250ML

처방전 유형:

Prescription

치료 영역:

EXTENDED-SPECTRUM PENICILLINS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2022-06-01

제품 특성 요약

                                _Pr_
_Piperacillin and Tazobactam for Injection _
_ _
_Page 1 of 46 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PIPERACILLIN AND TAZOBACTAM FOR INJECTION
Piperacillin Sodium and Tazobactam Sodium
2 g/0.25 g, 3 g/0.375 g, 4 g/0.5 g per vial (as piperacillin sodium
and tazobactam sodium)
Sterile Lyophilized Powder for Injection
For Intravenous Use Only
House Standard
Antibiotic/ß-lactamase Inhibitor
Hikma Canada Limited
5995 Avebury Road
Suite 804
Mississauga, Ontario
L5R 3P9
Date of Preparation: May 27, 2022
SUBMISSION CONTROL NO: 263855
_Pr_
_Piperacillin and Tazobactam for Injection _
_ _
_Page 2 of 46 _
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
.............................................................................................................
13
DOSAGE AND ADMINISTRATION
.........................................................................................
14
OVERDOSAGE
...........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
19
STORAGE AND STABILITY
.....................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
.....................
                                
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