ROCURONIUM BROMIDE INJECTION SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

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产品特点 产品特点 (SPC)
05-05-2020

有效成分:

ROCURONIUM BROMIDE

可用日期:

JUNO PHARMACEUTICALS CORP.

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:

15G/50G

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:

APPROVED

授权日期:

2020-05-05

产品特点

                                _PRODUCT MONOGRAPH: Rocuronium Bromide Injection _
Page 1 of 33
PRODUCT MONOGRAPH
Pr
ROCURONIUM BROMIDE INJECTION
10 mg / mL, Solution for Injection, 5 mL vial
Sterile and Preservative Free
Non-depolarizing Skeletal Neuromuscular Blocking Agent
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Date of Revision:
May 5, 2020
Submission Control No.: 238579
_PRODUCT MONOGRAPH: Rocuronium Bromide Injection _
Page 2 of 33
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
......................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
26
PHARMACEUTICAL INFORMATION
.........................
                                
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