CISATRACURIUM BESYLATE INJECTION SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CISATRACURIUM (CISATRACURIUM BESYLATE)

제공처:

MYLAN PHARMACEUTICALS ULC

ATC 코드:

M03AC11

INN (International Name):

CISATRACURIUM

복용량:

2MG

약제 형태:

SOLUTION

구성:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

관리 경로:

INTRAVENOUS

패키지 단위:

10ML

처방전 유형:

Prescription

치료 영역:

NEUROMUSCULAR BLOCKING AGENTS

제품 요약:

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

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2018-06-15

제품 특성 요약

_ 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
...