ROCURONIUM BROMIDE INJECTION SDZ SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ROCURONIUM BROMIDE

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

M03AC09

INN (Kansainvälinen yleisnimi):

ROCURONIUM BROMIDE

Annos:

10MG

Lääkemuoto:

SOLUTION

Koostumus:

ROCURONIUM BROMIDE 10MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

2.5/5/10ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NEUROMUSCULAR BLOCKING AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2018-08-01

Valmisteyhteenveto

_Rocuronium Bromide Injection & Rocuronium Bromide Injection SDZ _
_Page 1 of 39 _
PRODUCT MONOGRAPH
PR
ROCURONIUM BROMIDE INJECTION
Rocuronium Bromide
10 mg/mL Solution for Injection
PR
ROCURONIUM BROMIDE INJECTION SDZ
Rocuronium Bromide
10 mg/mL Solution for Injection
Sterile
Non-depolarizing Skeletal Neuromuscular Blocking Agent
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision : April 1, 2015
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 183292
_Rocuronium Bromide Injection_
&
_Rocuronium Bromide Injection SDZ _
_Page 2 of 39 _
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
......................................................................