AMIODARONE HYDROCHLORIDE FOR INJECTION SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
27-10-2020
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Aktiv bestanddel:
AMIODARONE HYDROCHLORIDE
Tilgængelig fra:
JAMP PHARMA CORPORATION
ATC-kode:
C01BD01
INN (International Name):
AMIODARONE
Dosering:
50MG
Lægemiddelform:
SOLUTION
Sammensætning:
AMIODARONE HYDROCHLORIDE 50MG
Indgivelsesvej:
INTRAVENOUS
Enheder i pakken:
3ML
Recept type:
Prescription
Terapeutisk område:
CLASS III ANTIARRYTHMICS
Produkt oversigt:
Active ingredient group (AIG) number: 0118593002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2020-11-02
Produktets egenskaber
_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
..........
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