CISATRACURIUM BESYLATE INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

M03AC11

DCI (Dénomination commune internationale):

CISATRACURIUM

Dosage:

2MG

forme pharmaceutique:

SOLUTION

Composition:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

10ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NEUROMUSCULAR BLOCKING AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2018-06-15

Résumé des caractéristiques du produit

_ 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
...