AMIODARONE HYDROCHLORIDE FOR INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

AMIODARONE HYDROCHLORIDE

Disponibil de la:

JAMP PHARMA CORPORATION

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:

APPROVED

Data de autorizare:

2020-11-02

Caracteristicilor produsului

_Amiodarone Hydrochloride for Injection_
_Page 1 of 59_
PRODUCT MONOGRAPH
PR
AMIODARONE HYDROCHLORIDE FOR INJECTION
Amiodarone hydrochloride for injection, USP
Vials: 50 mg/mL
Antiarrhythmic Agent
JAMP Pharma Corporation
Date of Preparation: October 27, 2020
1310, rue Nobel
Boucherville, Québec,
Canada
J4B 5H3
Control Number: 235195
_Amiodarone Hydrochloride for Injection_
_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
.............................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........