ROCURONIUM BROMIDE INJECTION SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

ROCURONIUM BROMIDE

Prieinama:

SANDOZ CANADA INCORPORATED

ATC kodas:

M03AC09

INN (Tarptautinis Pavadinimas):

ROCURONIUM BROMIDE

Dozė:

10MG

Vaisto forma:

SOLUTION

Sudėtis:

ROCURONIUM BROMIDE 10MG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

10X5ML

Recepto tipas:

Prescription

Gydymo sritis:

NEUROMUSCULAR BLOCKING AGENTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2008-10-24

Prekės savybės

_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
....