البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
AMIODARONE HYDROCHLORIDE
PHARMASCIENCE INC
C01BD01
AMIODARONE
200MG
TABLET
AMIODARONE HYDROCHLORIDE 200MG
ORAL
100
Prescription
CLASS III ANTIARRYTHMICS
Active ingredient group (AIG) number: 0118593001; AHFS:
APPROVED
2000-07-07
PRODUCT MONOGRAPH PR PMS-AMIODARONE Amiodarone Tablets, BP 100 mg & 200 mg amiodarone hydrochloride ANTIARRHYTHMIC AGENT PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com DATE OF REVISION: June 20, 2016 Submission Control No.: 195599 _pms-AMIODARONE Product Monograph _ _Page 2 of 75 _ 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 ......................................................................................................... 26 DOSAGE AND ADMINISTRATION ..................................................................................... 31 OVERDOSAGE ....................................................................................................................... 33 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 34 STORAGE AND STABILITY ................................................................................................. 37 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 38 PART II: SCIENTIFIC INFORMATION ................................................................................39 PHARMACEUTICAL INFORMATION ................................................................................. 39 CLINICAL TRIALS ...................................................... اقرأ الوثيقة كاملة