ROCURONIUM BROMIDE INJECTION SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ROCURONIUM BROMIDE

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

M03AC09

INN (International Name):

ROCURONIUM BROMIDE

Dosering :

10MG

Legemiddelform:

SOLUTION

Sammensetning:

ROCURONIUM BROMIDE 10MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

5ML

Resept typen:

Prescription

Terapeutisk område:

NEUROMUSCULAR BLOCKING AGENTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-01-04

Preparatomtale

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
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Submission Control No.: 225871
Date of Revision:
May 31, 2019
_Product Monograph - _
_Pr_
_Rocuronium Bromide Injection _
_Page 2 of 36 _
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 TR