ROCURONIUM BROMIDE INJECTION SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ROCURONIUM BROMIDE

Saadav alates:

OMEGA LABORATORIES LIMITED

ATC kood:

M03AC09

INN (Rahvusvaheline Nimetus):

ROCURONIUM BROMIDE

Annus:

10MG

Ravimvorm:

SOLUTION

Koostis:

ROCURONIUM BROMIDE 10MG

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

10X5ML/10X10ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

NEUROMUSCULAR BLOCKING AGENTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2012-03-23

Toote omadused

_Rocuronium Bromide Injection Product Monograph _
_Page 1 of 35 _
PRODUCT MONOGRAPH
Pr
ROCURONIUM BROMIDE INJECTION
Rocuronium Bromide
10 mg/mL Solution for Injection
Non-depolarizing Skeletal Neuromuscular Blocking Agent
Omega Laboratories Ltd.
11 177 Hamon
Montréal, Québec, H3M 3E4
Date of Preparation:
March 23, 2012
Submission Control No. 140885
_Rocuronium Bromide Injection Product Monograph _
_Page 2 of 35 _
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
.........................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
.....................................................18
STORAGE AND STABILITY
....................................................................................26
SPECIAL HANDLING INSTRUCTIONS
................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................... 26
PART II: SCIENTIFIC INFORMATION
................................................................28
PHARMACEUTICAL INFORMATION
....................................................................28
CLINICAL TRIALS
..............................................................................