CISATRACURIUM BESYLATE INJECTION SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Tilgængelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

M03AC11

INN (International Name):

CISATRACURIUM

Dosering:

2MG

Lægemiddelform:

SOLUTION

Sammensætning:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

10ML

Recept type:

Prescription

Terapeutisk område:

NEUROMUSCULAR BLOCKING AGENTS

Produkt oversigt:

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

Autorisation status:

CANCELLED PRE MARKET

Autorisation dato:

2018-06-15

Produktets egenskaber

_ 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
...