PHL-AMIODARONE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

AMIODARONE HYDROCHLORIDE

Доступно од:

PHARMEL INC

АТЦ код:

C01BD01

INN (Међународно име):

AMIODARONE

Дозирање:

100MG

Фармацеутски облик:

TABLET

Састав:

AMIODARONE HYDROCHLORIDE 100MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

CLASS III ANTIARRYTHMICS

Резиме производа:

Active ingredient group (AIG) number: 0118593003; AHFS:

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2017-09-12

Карактеристике производа

PRODUCT MONOGRAPH
Pr
phl-AMIODARONE
Amiodarone Tablets, BP
100 mg & 200 mg amiodarone hydrochloride
Antiarrhythmic Agent
PHARMEL INC.
DATE OF REVISION:
6111 Royalmount Ave, Suite #100
April 25, 2013
Montreal, Quebec
H4P 2T4
Control No. : 163813
_phl-AMIODARONE Product Monograph _
_Page 2 of 71 _
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
.......................................................................................................
22
DOSAGE AND ADMINISTRATION
..................................................................................
27
OVERDOSAGE
......................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 30
STORAGE AND
STABILITY...............................................................................................
34
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 34
PART II: SCIENTIFIC INFORMATION
................................................................................36
PHARMACEUTICAL INFORMATION
.................................................................................
36
CLINICAL TRIALS
.