Ország: Kanada
Nyelv: angol
Forrás: Health Canada
AMLODIPINE (AMLODIPINE BESYLATE)
NORA PHARMA INC
C08CA01
AMLODIPINE
2.5MG
TABLET
AMLODIPINE (AMLODIPINE BESYLATE) 2.5MG
ORAL
100
Prescription
DIHYDROPYRIDINES
Active ingredient group (AIG) number: 0131437003; AHFS:
CANCELLED POST MARKET
2022-07-25
PRODUCT MONOGRAPH PR AMLODIPINE TABLETS AMLODIPINE BESYLATE TABLETS HOUSE STD. 2.5 MG, 5 MG AND 10 MG AMLODIPINE (AS AMLODIPINE BESYLATE) ANTIHYPERTENSIVE/ANTIANGINAL AGENT NORA PHARMA INC. 40 Prince-Arthur, Suite 310 Saint-Lambert, Quebec J4P 1X2 SUBMISSION CONTROL NO. 262285 Date of Revision: April 7, 2022 Page 2 of 39 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 ........................................................................................................... 6 DRUG INTERACTIONS ........................................................................................................... 9 DOSAGE AND ADMINISTRATION ..................................................................................... 16 OVERDOSAGE ........................................................................................................................ 16 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 17 STORAGE AND STABILITY ................................................................................................. 20 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 20 PART II: SCIENTIFIC INFORMATION................................................................................ 22 PHARMACEUTICAL INFORMATION ................................................................................. 22 DETAILED PHARMACOLOGY ...................................................... Olvassa el a teljes dokumentumot