ROCURONIUM BROMIDE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROCURONIUM BROMIDE

Available from:

JUNO PHARMACEUTICALS CORP.

ATC code:

M03AC09

INN (International Name):

ROCURONIUM BROMIDE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

ROCURONIUM BROMIDE 10MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

NEUROMUSCULAR BLOCKING AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-05-05

Summary of Product characteristics

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