ROCURONIUM BROMIDE INJECTION SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ROCURONIUM BROMIDE

Saatavilla:

AURO PHARMA INC

ATC-koodi:

M03AC09

INN (Kansainvälinen yleisnimi):

ROCURONIUM BROMIDE

Annos:

10MG

Lääkemuoto:

SOLUTION

Koostumus:

ROCURONIUM BROMIDE 10MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NEUROMUSCULAR BLOCKING AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2020-05-07

Valmisteyhteenveto

Page 1 of 35
PRODUCT MONOGRAPH
PR ROCURONIUM BROMIDE INJECTION
10 mg/mL Solution for Injection
(50 mg/5 mL and 100 mg/10 mL)
Sterile Solution
Non-depolarizing
Skeletal Neuromuscular Blocking Agent
AURO PHARMA INC. Date of Preparation:
3700 Steeles Avenue West, Suite # 402 May 5, 2020
Woodbridge, Ontario, L4L 8K8,
Canada
Submission
Control No:
213553
Page 2 of 35
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
..................................................................................................
25
SPECIAL HANDLING
INSTRUCTIONS.................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 26
PART II: SCIENTIFIC
INFORMATION.................................................................................
27
PHARMACEUTICAL
INFO