AJ-CISATRACURIUM SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Available from:

AGILA JAMP CANADA INC

ATC code:

M03AC11

INN (International Name):

CISATRACURIUM

Dosage:

2MG

Pharmaceutical form:

SOLUTION

Composition:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Administration route:

INTRAVENOUS

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

NEUROMUSCULAR BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0133260001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2015-11-03

Summary of Product characteristics

_AJ-CISATRACURIUM (Cisatracurium Besylate Injection) preservative-free
Product Monograph _
_Page 1 of 30 _
PRODUCT MONOGRAPH
PR
AJ-CISATRACURIUM CISATRACURIUM BESYLATE INJECTION
PRESERVATIVE-FREE
SOLUTION FOR INJECTION
2 MG/ML CISATRACURIUM (AS CISATRACURIUM BESYLATE)
5 ML SINGLE DOSE VIAL
NON-DEPOLARIZING SKELETAL NEUROMUSCULAR BLOCKING AGENT
THIS DRUG SHOULD BE ADMINISTERED ONLY BY ADEQUATELY TRAINED
PROFESSIONALS FAMILIAR
WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
AGILA-JAMP CANADA INC.
1380 – 203 Newton Street
Boucherville, Quebec
Canada
J4B 5H2
DATE OF PREPARATION:
July 17, 2013
CONTROL NO.: 165928
_AJ-CISATRACURIUM (Cisatracurium Besylate Injection) preservative-free
Product Monograph _
_Page 2 of 30 _
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
............................................................................................................
9
DOSAGE AND ADMINISTRATION
......................................................................................
10
OVERDOSAGE
.........................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
16
STORAGE AND STABILITY
..........................................................................................