ROCURONIUM BROMIDE INJECTION SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ROCURONIUM BROMIDE

זמין מ:

SANDOZ CANADA INCORPORATED

קוד ATC:

M03AC09

INN (שם בינלאומי):

ROCURONIUM BROMIDE

כמות:

10MG

טופס פרצבטיות:

SOLUTION

הרכב:

ROCURONIUM BROMIDE 10MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

10X5ML

סוג מרשם:

Prescription

איזור תרפויטי:

NEUROMUSCULAR BLOCKING AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2008-10-24

מאפייני מוצר

_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
....