AMIODARONE OMEGA SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

AMIODARONE HYDROCHLORIDE

Доступно од:

OMEGA LABORATORIES LIMITED

АТЦ код:

C01BD01

INN (Међународно име):

AMIODARONE

Дозирање:

50MG

Фармацеутски облик:

SOLUTION

Састав:

AMIODARONE HYDROCHLORIDE 50MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

CLASS III ANTIARRYTHMICS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2004-04-05

Карактеристике производа

_Amiodarone Omega _
_Page 1 of 59 _
PRODUCT MONOGRAPH PR
AMIODARONE OMEGA
Amiodarone hydrochloride for injection
House Standard
Vials: 50 mg/mL
Antiarrhythmic Agent
Omega Laboratories Limited.
Date of Revision: June 4, 2018
11 177 Hamon
Montreal, Quebec
H3M 3E4
Control Number: 213232
_Amiodarone Omega _
_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
.............................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 30
PART II: SCIENT