ROCURONIUM BROMIDE INJECTION SDZ SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

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下载 产品特点 (SPC)
10-04-2015

有效成分:

ROCURONIUM BROMIDE

可用日期:

SANDOZ CANADA INCORPORATED

ATC代码:

M03AC09

INN(国际名称):

ROCURONIUM BROMIDE

剂量:

10MG

药物剂型:

SOLUTION

组成:

ROCURONIUM BROMIDE 10MG

给药途径:

INTRAVENOUS

每包单位数:

2.5/5/10ML

处方类型:

Prescription

治疗领域:

NEUROMUSCULAR BLOCKING AGENTS

產品總結:

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

授权状态:

CANCELLED PRE MARKET

授权日期:

2018-08-01

产品特点

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