CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Available from:

OMEGA LABORATORIES LIMITED

ATC code:

M03AC11

INN (International Name):

CISATRACURIUM

Dosage:

2MG

Pharmaceutical form:

SOLUTION

Composition:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Administration route:

INTRAVENOUS

Units in package:

10*5ML

Prescription type:

Prescription

Therapeutic area:

NEUROMUSCULAR BLOCKING AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2013-06-28

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
C
ISATRACURIUM
O
MEGA
S
INGLE
D
OSE
Cisatracurium Besylate Injection
2 mg/mL cisatracurium
(5 mL single dose vial)
PR
C
ISATRACURIUM
O
MEGA
M
ULTI
-D
OSE
Cisatracurium Besylate Injection
2 mg/mL cisatracurium
(10 mL multiple dose vial)
NON-DEPOLARIZING SKELETAL NEUROMUSCULAR BLOCKING AGENT
Sterile solution
THIS DRUG SHOULD BE ADMINISTERED ONLY BY ADEQUATELY TRAINED
PROFESSIONALS FAMILIAR
WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
Omega Laboratories Limited
11 177, Hamon
Montreal, Canada
H3M 3E4
DATE OF PREPARATION
:
June 27, 2013
SUBMISSION CONTROL NO: 138615
Page
2
of
37
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
.............................................................................................
10
DRUG INTERACTIONS
.............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
13
OVERDOSAGE
............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 20
STORAGE AND STABILITY
.....................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
................................................................... 28
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 28
PART II: SCIENTIFIC INFORMATION
...................................