APO-AMIODARONE TABLETS

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

AMIODARONE HYDROCHLORIDE

থেকে পাওয়া:

APOTEX INC

এটিসি কোড:

C01BD01

INN (আন্তর্জাতিক নাম):

AMIODARONE

ডোজ:

200MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

AMIODARONE HYDROCHLORIDE 200MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

CLASS III ANTIARRYTHMICS

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2002-07-30

পণ্য বৈশিষ্ট্য

Page 1 of 64
PRODUCT MONOGRAPH
APO-AMIODARONE
AMIODARONE TABLETS BP
200 MG AMIODARONE HYDROCHLORIDE
ANTIARRHYTHMIC AGENT
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
CANADA M9L 1T9
APRIL 6, 2017
CONTROL #204336
Page 2 of 64
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
......................................................................................................
25
DOSAGE AND ADMINISTRATION
..................................................................................
30
OVERDOSAGE
....................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 33
STORAGE AND STABILITY
..............................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 37
PART II: SCIENTIFIC INFORMATION
..............................................................................
38
PHARMACEUTICAL INFORMATION
..............................................................................
38
CLINICAL TRIALS
..............................................................................................................
38
DETAILED PHARMACOLOGY
.................................................