CISATRACURIUM OMEGA MULTIDOSE SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

CISATRACURIUM (CISATRACURIUM BESYLATE)

から入手可能:

OMEGA LABORATORIES LIMITED

ATCコード:

M03AC11

INN（国際名）:

CISATRACURIUM

投薬量:

2MG

医薬品形態:

SOLUTION

構図:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

10*10ML

処方タイプ:

Prescription

治療領域:

NEUROMUSCULAR BLOCKING AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2013-06-28

製品の特徴

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