PIPERACILLIN AND TAZOBACTAM FOR INJECTION POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)

제공처:

MYLAN PHARMACEUTICALS ULC

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:

100

처방전 유형:

Prescription

치료 영역:

EXTENDED-SPECTRUM PENICILLINS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2016-07-28

제품 특성 요약

PRODUCT
MONOGRAPH
PR
PIPERACILLIN AND TAZOBACTAM
FOR
INJECTION
Sterile piperacillin sodium and tazobactam sodium
Lyophilized Powder for Injection
For Intravenous Use
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
Antibiotic/ß-lactamase Inhibitor
Mylan Pharmaceuticals ULC
Date of Revision:
85 Advance Road
February 18, 2015
Etobicoke, ON
M8Z 2S6
Submission Control No: 181371
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PAGE 2 OF 42
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
............................................................................
3
INDICATIONS
AND
CLINICAL
USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
ADVERSE
REACTIONS
.........................................................................................................
8
DRUG
INTERACTIONS
.......................................................................................................
12
DOSAGE
AND
ADMINISTRATION
...................................................................................
14
OVERDOSAGE
......................................................................................................................
18
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................ 19
STORAGE
AND
STABILITY
...............................................................................................
21
SPECIAL
HANDLING
INSTRUCTIONS
...........................................................................
21
DOSAGE
FORMS,
COMPOSITION
AND