Država: Kanada
Jezik: engleski
Izvor: Health Canada
AMIODARONE HYDROCHLORIDE
MYLAN PHARMACEUTICALS ULC
C01BD01
AMIODARONE
200MG
TABLET
AMIODARONE HYDROCHLORIDE 200MG
ORAL
100
Prescription
CLASS III ANTIARRYTHMICS
Active ingredient group (AIG) number: 0118593001; AHFS:
CANCELLED POST MARKET
2018-07-12
PAGE 1 OF 64 PRODUCT MONOGRAPH PR MYLAN-AMIODARONE (Amiodarone Hydrochloride Tablets, BP) 200 MG Antiarrhythmic Agent Mylan Pharmaceuticals ULC Date of revision: 85 Advance Road April 14, 2016 Etobicoke, Ontario M8Z 2S6 Control number: 193651 PAGE 2 OF 64 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ................................................................................ 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS ......................................................................................................... 20 DRUG INTERACTIONS ......................................................................................................... 23 DOSAGE AND ADMINISTRATION ..................................................................................... 29 OVERDOSAGE ....................................................................................................................... 31 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 32 STORAGE AND STABILITY ............................................................................................... 36 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 36 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 36 PART II: SCIENTIFIC INFORMATION .............................................................................. 37 PHARMACEUTICAL INFORMATION ................................................................................. 37 CLINICAL TRIALS ............................... Pročitajte cijeli dokument