CISATRACURIUM BESYLATE INJECTION SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Verfügbar ab:

MYLAN PHARMACEUTICALS ULC

ATC-Code:

M03AC11

INN (Internationale Bezeichnung):

CISATRACURIUM

Dosierung:

2MG

Darreichungsform:

SOLUTION

Zusammensetzung:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

10ML

Verschreibungstyp:

Prescription

Therapiebereich:

NEUROMUSCULAR BLOCKING AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED PRE MARKET

Berechtigungsdatum:

2018-06-15

Fachinformation

_ 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
...