AMIODARONE HYDROCHLORIDE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMIODARONE HYDROCHLORIDE

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

C01BD01

INN (International Name):

AMIODARONE

Dosage:

50MG

Pharmaceutical form:

SOLUTION

Composition:

AMIODARONE HYDROCHLORIDE 50MG

Administration route:

INTRAVENOUS

Units in package:

3ML

Prescription type:

Prescription

Therapeutic area:

CLASS III ANTIARRYTHMICS

Product summary:

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

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2022-02-24

Summary of Product characteristics

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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: 202861
Date of Revision: March 1, 2017
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_Page 2 of 59_
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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
.............................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
25
STORAGE AND STABILITY
......................................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 29
PART II: SCIENTIFIC INFORMATION
.....................................................................................
30
PHARMACEUTICAL INFORMA