AMIODARONE HYDROCHLORIDE INJECTION SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

AMIODARONE HYDROCHLORIDE

Saadav alates:

MYLAN PHARMACEUTICALS ULC

ATC kood:

C01BD01

INN (Rahvusvaheline Nimetus):

AMIODARONE

Annus:

50MG

Ravimvorm:

SOLUTION

Koostis:

AMIODARONE HYDROCHLORIDE 50MG

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

10X3ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

CLASS III ANTIARRYTHMICS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2016-07-06

Toote omadused

_Amiodarone Hydrochloride Injection _
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_Page 1 of 58_
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PRODUCT MONOGRAPH
PR AMIODARONE HYDROCHLORIDE INJECTION
(Amiodarone Sterile Concentrate, BP)
50 mg/mL
Antiarrhythmic Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No: 193735
Date of Revision: May 3, 2016
_Amiodarone Hydrochloride Injection _
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_Page 2 of 58_
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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
..............................................................................................................
14
DRUG INTERACTIONS
...............................................................................................................
17
DOSAGE AND ADMINISTRATION
...........................................................................................
21
OVERDOSAGE
.............................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
25
STORAGE AND STABILITY
......................................................................................................
28
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 28
PART II: SCIENTIFIC INFORMATION
..............................................