ROCURONIUM BROMIDE INJECTION SDZ SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ROCURONIUM BROMIDE

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

M03AC09

INN (국제 이름):

ROCURONIUM BROMIDE

복용량:

10MG

약제 형태:

SOLUTION

구성:

ROCURONIUM BROMIDE 10MG

관리 경로:

INTRAVENOUS

패키지 단위:

2.5/5/10ML

처방전 유형:

Prescription

치료 영역:

NEUROMUSCULAR BLOCKING AGENTS

제품 요약:

Active ingredient group (AIG) number: 0126317001; AHFS:

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2018-08-01

제품 특성 요약

_Rocuronium Bromide Injection & Rocuronium Bromide Injection SDZ _
_Page 1 of 39 _
PRODUCT MONOGRAPH
PR
ROCURONIUM BROMIDE INJECTION
Rocuronium Bromide
10 mg/mL Solution for Injection
PR
ROCURONIUM BROMIDE INJECTION SDZ
Rocuronium Bromide
10 mg/mL Solution for Injection
Sterile
Non-depolarizing Skeletal Neuromuscular Blocking Agent
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision : April 1, 2015
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 183292
_Rocuronium Bromide Injection_
&
_Rocuronium Bromide Injection SDZ _
_Page 2 of 39 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
......................................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................................
3
CONTRAINDICATIONS
.................................................................................................................
4
WARNINGS AND PRECAUTIONS
................................................................................................
4
ADVERSE REACTIONS
..................................................................................................................
8
DRUG INTERACTIONS
................................................................................................................
11
DOSAGE AND ADMINISTRATION
............................................................................................
12
OVERDOSAGE
..............................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
18
STORAGE AND STABILITY
........................................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
......................................................................