CISATRACURIUM BESYLATE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

M03AC11

INN (International Name):

CISATRACURIUM

Dosage:

2MG

Pharmaceutical form:

SOLUTION

Composition:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Administration route:

INTRAVENOUS

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

NEUROMUSCULAR BLOCKING AGENTS

Product summary:

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

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2018-06-15

Summary of Product characteristics

_ Page 1 of 31 _
PRODUCT MONOGRAPH
PR
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.
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation: August 18, 2014
Control No.: 176645
_ 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
................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 24
PART II: SCIENTIFIC INFORMATION
................................................................................
25
PHARMACEUTICAL INFORMATION
...