CISATRACURIUM OMEGA SINGLE DOSE SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Доступна з:

OMEGA LABORATORIES LIMITED

Код атс:

M03AC11

ІПН (Міжнародна Ім'я):

CISATRACURIUM

Дозування:

2MG

Фармацевтична форма:

SOLUTION

Склад:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

10*5ML

Тип рецепту:

Prescription

Терапевтична области:

NEUROMUSCULAR BLOCKING AGENTS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

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