CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Disponible depuis:

OMEGA LABORATORIES LIMITED

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:

10*5ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NEUROMUSCULAR BLOCKING AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2013-06-28

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
C
ISATRACURIUM
O
MEGA
S
INGLE
D
OSE
Cisatracurium Besylate Injection
2 mg/mL cisatracurium
(5 mL single dose vial)
PR
C
ISATRACURIUM
O
MEGA
M
ULTI
-D
OSE
Cisatracurium Besylate Injection
2 mg/mL cisatracurium
(10 mL multiple dose vial)
NON-DEPOLARIZING SKELETAL NEUROMUSCULAR BLOCKING AGENT
Sterile solution
THIS DRUG SHOULD BE ADMINISTERED ONLY BY ADEQUATELY TRAINED
PROFESSIONALS FAMILIAR
WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
Omega Laboratories Limited
11 177, Hamon
Montreal, Canada
H3M 3E4
DATE OF PREPARATION
:
June 27, 2013
SUBMISSION CONTROL NO: 138615
Page
2
of
37
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT
INFORMATION....................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
.............................................................................................
10
DRUG INTERACTIONS
.............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
13
OVERDOSAGE
............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 20
STORAGE AND STABILITY
.....................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
................................................................... 28
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 28
PART II: SCIENTIFIC INFORMATION
...................................