AMIODARONE HYDROCHLORIDE FOR INJECTION SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

AMIODARONE HYDROCHLORIDE

Inapatikana kutoka:

SANDOZ CANADA INCORPORATED

ATC kanuni:

C01BD01

INN (Jina la Kimataifa):

AMIODARONE

Kipimo:

50MG

Dawa fomu:

SOLUTION

Tungo:

AMIODARONE HYDROCHLORIDE 50MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

3/6/9/18ML

Dawa ya aina:

Prescription

Eneo la matibabu:

CLASS III ANTIARRYTHMICS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2005-08-08

Tabia za bidhaa

_Amiodarone Hydrochloride for Injection Page 1 of 58 _
PRODUCT MONOGRAPH
PR
AMIODARONE HYDROCHLORIDE FOR INJECTION
Amiodarone hydrochloride for injection
Vials: 50 mg/mL
Antiarrhythmic Agent
Date of Preparation: September 30, 2011
Sandoz Canada Inc.
Date of Revision: November 20, 2023
110, De Lauzon Street
Boucherville, QC, Canada
J4B 1E6
Control Number: 277176
_Amiodarone Hydrochloride for Injection Page 2 of 58 _
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
.......................................................................................................................
17
DOSAGE AND ADMINISTRATION
...................................................................................................
22
OVERDOSAGE
.....................................................................................................................................
26
ACTION AND CLINICAL
PHARMACOLOGY..................................................................................
26
STORAGE AND STABILITY
...............................................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
............................................................................................
30
DOSAGE FORMS, COMPOSITION AND