ROCURONIUM BROMIDE INJECTION SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ROCURONIUM BROMIDE

Disponible desde:

JUNO PHARMACEUTICALS CORP.

Código ATC:

M03AC09

Designación común internacional (DCI):

ROCURONIUM BROMIDE

Dosis:

10MG

formulario farmacéutico:

SOLUTION

Composición:

ROCURONIUM BROMIDE 10MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

NEUROMUSCULAR BLOCKING AGENTS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2020-05-05

Ficha técnica

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