CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Доступна с:

OMEGA LABORATORIES LIMITED

код АТС:

M03AC11

ИНН (Международная Имя):

CISATRACURIUM

дозировка:

2MG

Фармацевтическая форма:

SOLUTION

состав:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Администрация маршрут:

INTRAVENOUS

Штук в упаковке:

10*5ML

Тип рецепта:

Prescription

Терапевтические области:

NEUROMUSCULAR BLOCKING AGENTS

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2013-06-28

Характеристики 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
...................................