CISATRACURIUM BESYLATE INJECTION SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Beschikbaar vanaf:

MYLAN PHARMACEUTICALS ULC

ATC-code:

M03AC11

INN (Algemene Internationale Benaming):

CISATRACURIUM

Dosering:

2MG

farmaceutische vorm:

SOLUTION

Samenstelling:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

10ML

Prescription-type:

Prescription

Therapeutisch gebied:

NEUROMUSCULAR BLOCKING AGENTS

Product samenvatting:

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

Autorisatie-status:

CANCELLED PRE MARKET

Autorisatie datum:

2018-06-15

Productkenmerken

_ 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
...