AMIODARONE SYRINGE SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

AMIODARONE HYDROCHLORIDE

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

C01BD01

INN (국제 이름):

AMIODARONE

복용량:

50MG

약제 형태:

SOLUTION

구성:

AMIODARONE HYDROCHLORIDE 50MG

관리 경로:

INTRAVENOUS

패키지 단위:

3ML

처방전 유형:

Prescription

치료 영역:

CLASS III ANTIARRYTHMICS

제품 요약:

Active ingredient group (AIG) number: 0118593002; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2020-04-30

제품 특성 요약

_Amiodarone Hydrochloride for Injection/Amiodarone Syringe _
_Page 1 of 59 _
PRODUCT MONOGRAPH
PR
AMIODARONE HYDROCHLORIDE FOR INJECTION
Amiodarone hydrochloride for injection
Vials: 50 mg/mL
PR
AMIODARONE SYRINGE
Amiodarone hydrochloride for injection
Pre-filled syringes: 50 mg/mL
Antiarrhythmic Agent
Sandoz Canada Inc.
Date of Revision: December 6, 2016
145 Jules-Léger St.
Boucherville, QC, Canada
J4B 7K8
Control Number: 198348
_Amiodarone Hydrochloride for Injection/Amiodarone Syringe _
_Page 2 of 59 _
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
.......................................................................................................................
15
DRUG INTERACTIONS
.......................................................................................................................
18
DOSAGE AND ADMINISTRATION
...................................................................................................
22
OVERDOSAGE
.....................................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
27
STORAGE AND STABILITY
...............................................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
................................