AMIODARONE SYRINGE SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

AMIODARONE HYDROCHLORIDE

Dostupné s:

SANDOZ CANADA INCORPORATED

ATC kód:

C01BD01

INN (Mezinárodní Name):

AMIODARONE

Dávkování:

50MG

Léková forma:

SOLUTION

Složení:

AMIODARONE HYDROCHLORIDE 50MG

Podání:

INTRAVENOUS

Jednotky v balení:

3ML

Druh předpisu:

Prescription

Terapeutické oblasti:

CLASS III ANTIARRYTHMICS

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2020-04-30

Charakteristika produktu

_Amiodarone Hydrochloride for Injection/Amiodarone Syringe _
_Page 1 of 59 _
PRODUCT MONOGRAPH
PR
AMIODARONE HYDROCHLORIDE FOR INJECTION
Amiodarone hydrochloride for injection
Vials: 50 mg/mL
PR
AMIODARONE SYRINGE
Amiodarone hydrochloride for injection
Pre-filled syringes: 50 mg/mL
Antiarrhythmic Agent
Sandoz Canada Inc.
Date of Revision: December 6, 2016
145 Jules-Léger St.
Boucherville, QC, Canada
J4B 7K8
Control Number: 198348
_Amiodarone Hydrochloride for Injection/Amiodarone Syringe _
_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
................................