AMIODARONE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

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제품 특성 요약 제품 특성 요약 (SPC)
28-10-2016

유효 성분:

AMIODARONE HYDROCHLORIDE

제공처:

SIVEM PHARMACEUTICALS ULC

ATC 코드:

C01BD01

INN (International Name):

AMIODARONE

복용량:

200MG

약제 형태:

TABLET

구성:

AMIODARONE HYDROCHLORIDE 200MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

CLASS III ANTIARRYTHMICS

제품 요약:

Active ingredient group (AIG) number: 0118593001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2012-05-31

제품 특성 요약

                                _ _
_Amiodarone _
_Page 1 of 65_
_ _
_ _
PRODUCT MONOGRPAH
PR
AMIODARONE
Amiodarone Hydrochloride tablets, BP
200 mg
Antiarrhythmic Agent
SIVEM PHARMACEUTICALS ULC
Date of Revision:
4705 Dobrin Street
October 27, 2016
St. Laurent, Quebec
H4R 2P7
www.sivem.ca
Control number: 198891
_ _
_Amiodarone _
_Page 2 of 65_
_ _
_ _
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
.......................................................................................................................................
19
DRUG
INTERACTIONS........................................................................................................................................
23
DOSAGE
AND
ADMINISTRATION
....................................................................................................................
28
OVERDOSAGE
......................................................................................................................................................
30
ACTION
AND
CLINICAL
PHARMACOLOGY
...................................................................................................
31
STORAGE
AND
STABILITY
................................................................................................................................
34
SPECIAL
HANDLING
INSTRUCTIONS
....................................
                                
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