Nazione: Canada
Lingua: inglese
Fonte: Health Canada
AMIODARONE HYDROCHLORIDE
SIVEM PHARMACEUTICALS ULC
C01BD01
AMIODARONE
200MG
TABLET
AMIODARONE HYDROCHLORIDE 200MG
ORAL
100
Prescription
CLASS III ANTIARRYTHMICS
Active ingredient group (AIG) number: 0118593001; AHFS:
APPROVED
2012-05-31
_ _ _Amiodarone _ _Page 1 of 65_ _ _ _ _ PRODUCT MONOGRPAH PR AMIODARONE Amiodarone Hydrochloride tablets, BP 200 mg Antiarrhythmic Agent SIVEM PHARMACEUTICALS ULC Date of Revision: 4705 Dobrin Street October 27, 2016 St. Laurent, Quebec H4R 2P7 www.sivem.ca Control number: 198891 _ _ _Amiodarone _ _Page 2 of 65_ _ _ _ _ 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 ....................................................................................................................................... 19 DRUG INTERACTIONS........................................................................................................................................ 23 DOSAGE AND ADMINISTRATION .................................................................................................................... 28 OVERDOSAGE ...................................................................................................................................................... 30 ACTION AND CLINICAL PHARMACOLOGY ................................................................................................... 31 STORAGE AND STABILITY ................................................................................................................................ 34 SPECIAL HANDLING INSTRUCTIONS .................................... Leggi il documento completo