ROCURONIUM BROMIDE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROCURONIUM BROMIDE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

M03AC09

INN (International Name):

ROCURONIUM BROMIDE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

ROCURONIUM BROMIDE 10MG

Administration route:

INTRAVENOUS

Units in package:

10X5ML

Prescription type:

Prescription

Therapeutic area:

NEUROMUSCULAR BLOCKING AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2008-10-24

Summary of Product characteristics

_Rocuronium Bromide Injection _
_Page 1 of 37 _
PRODUCT MONOGRAPH
PR
ROCURONIUM BROMIDE INJECTION
Rocuronium Bromide
10 mg/mL Solution for Injection
Sterile
Non-depolarizing Skeletal Neuromuscular Blocking Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Date of Revision: March 20, 2019
Boucherville, QC, Canada
J4B 1E6
Submission Control No: 224236
_Rocuronium Bromide Injection _
_Page 2 of 37 _
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
.....................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 27
PART II: SCIENTIFIC INFORMATION
....