ZEMURON SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROCURONIUM BROMIDE

Available from:

MERCK CANADA INC

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:

CANCELLED POST MARKET

Authorization date:

2018-02-05

Summary of Product characteristics

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_Page 1 of 35_
PRODUCT MONOGRAPH
ZEMURON
®
Rocuronium Bromide
10 mg/mL Solution for Injection
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Non-depolarizing Skeletal Neuromuscular Blocking Agent
MERCK CANADA INC.
Date of Revision:
16750 route Transcanadienne
November 5, 2018
Kirkland, QC Canada H9H 4M7
www.merck.ca
Submission Control No: 220017
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_Page 2 of 35_
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TABLE OF CONTENTS
[To create the table of contents, select from the
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
.........................................................................................................
12
DOSAGE AND ADMINISTRATION
.....................................................................................
13
OVERDOSAGE
.......................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 18
STORAGE AND STABILITY
.................................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................28
PHARMACEUTI