CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Disponível em:

OMEGA LABORATORIES LIMITED

Código ATC:

M03AC11

DCI (Denominação Comum Internacional):

CISATRACURIUM

Dosagem:

2MG

Forma farmacêutica:

SOLUTION

Composição:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Via de administração:

INTRAVENOUS

Unidades em pacote:

10*5ML

Tipo de prescrição:

Prescription

Área terapêutica:

NEUROMUSCULAR BLOCKING AGENTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2013-06-28

Características técnicas

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
...................................