CISATRACURIUM OMEGA MULTIDOSE SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Предлага се от:

OMEGA LABORATORIES LIMITED

АТС код:

M03AC11

INN (Международно Name):

CISATRACURIUM

дозиране:

2MG

Лекарствена форма:

SOLUTION

Композиция:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

10*10ML

Вид предписание :

Prescription

Терапевтична област:

NEUROMUSCULAR BLOCKING AGENTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2013-06-28

Данни за продукта

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