AJ-CISATRACURIUM SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

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SPC SPC (SPC)
19-07-2013

active_ingredient:

CISATRACURIUM (CISATRACURIUM BESYLATE)

MAH:

AGILA JAMP CANADA INC

ATC_code:

M03AC11

INN:

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

leaflet_short:

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

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2015-11-03

SPC

                                _AJ-CISATRACURIUM (Cisatracurium Besylate Injection) Product Monograph
_
_Page 1 of 31 _
PRODUCT MONOGRAPH
PR
AJ-CISATRACURIUM
CISATRACURIUM BESYLATE INJECTION
SOLUTION FOR INJECTION
2 MG/ML CISATRACURIUM (AS CISATRACURIUM BESYLATE)
10 ML MULTIPLE 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) Product Monograph
_
_Page 2 of 31 _
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
............................................................................................................
9
DRUG INTERACTIONS
..........................................................................................................
10
DOSAGE AND ADMINISTRATION
......................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
16
STORAGE AND STABILITY
..................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................
                                
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