AMIODARONE SYRINGE SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

AMIODARONE HYDROCHLORIDE

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

C01BD01

INN (nume internaţional):

AMIODARONE

Dozare:

50MG

Forma farmaceutică:

SOLUTION

Compoziție:

AMIODARONE HYDROCHLORIDE 50MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

3ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

CLASS III ANTIARRYTHMICS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2020-04-30

Caracteristicilor produsului

_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
................................