CISATRACURIUM BESYLATE INJECTION 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:

MYLAN PHARMACEUTICALS ULC

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:

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:

CANCELLED PRE MARKET

承認日:

2018-06-15

製品の特徴

_ Page 1 of 31 _
PRODUCT MONOGRAPH
PR
CISATRACURIUM BESYLATE INJECTION
SOLUTION FOR INJECTION
2 MG/ML CISATRACURIUM (AS CISATRACURIUM BESYLATE)
10 ML MULTIPLE DOSE VIAL
NON-DEPOLARIZING SKELETAL NEUROMUSCULAR BLOCKING AGENT
THIS DRUG SHOULD BE ADMINISTERED ONLY BY ADEQUATELY TRAINED
PROFESSIONALS FAMILIAR
WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation: August 18, 2014
Control No.: 176645
_ Page 2 of 31 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
3
CONTRAINDICATIONS
............................................................................................................
3
WARNINGS AND PRECAUTIONS
..........................................................................................
4
ADVERSE REACTIONS
............................................................................................................
9
DRUG INTERACTIONS
..........................................................................................................
10
DOSAGE AND ADMINISTRATION
......................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
16
STORAGE AND STABILITY
..................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 24
PART II: SCIENTIFIC INFORMATION
................................................................................
25
PHARMACEUTICAL INFORMATION
...