ROCURONIUM BROMIDE INJECTION SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

ROCURONIUM BROMIDE

Tillgänglig från:

SANDOZ CANADA INCORPORATED

ATC-kod:

M03AC09

INN (International namn):

ROCURONIUM BROMIDE

Dos:

10MG

Läkemedelsform:

SOLUTION

Sammansättning:

ROCURONIUM BROMIDE 10MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

10X5ML

Receptbelagda typ:

Prescription

Terapiområde:

NEUROMUSCULAR BLOCKING AGENTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2008-10-24

Produktens egenskaper

_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
....