AMIODARONE HYDROCHLORIDE INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

AMIODARONE HYDROCHLORIDE

Disponibil de la:

MYLAN PHARMACEUTICALS ULC

Codul ATC:

C01BD01

INN (nume internaţional):

AMIODARONE

Dozare:

50MG

Forma farmaceutică:

SOLUTION

Compoziție:

AMIODARONE HYDROCHLORIDE 50MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

10X3ML

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:

2016-07-06

Caracteristicilor produsului

_Amiodarone Hydrochloride Injection _
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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: 193735
Date of Revision: May 3, 2016
_Amiodarone Hydrochloride Injection _
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_Page 2 of 58_
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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
.............................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
25
STORAGE AND STABILITY
......................................................................................................
28
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 28
PART II: SCIENTIFIC INFORMATION
..............................................