Land: Canada
Språk: engelsk
Kilde: Health Canada
PERINDOPRIL ARGININE
APOTEX INC
C09AA04
PERINDOPRIL
5MG
TABLET
PERINDOPRIL ARGININE 5MG
ORAL
30/100/500/1000
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0151321002; AHFS:
APPROVED
2018-03-09
_APO-PERINDOPRIL ARGININE PRODUCT MONOGRAPH _ _Page 1 of 68_ _ _ PRODUCT MONOGRAPH PR APO-PERINDOPRIL ARGININE Perindopril Arginine Tablets 2.5 mg, 5 mg and 10 mg Angiotensin Converting Enzyme Inhibitor APOTEX INC. DATE OF PREPARATION: 150 SIGNET DRIVE April 24, 2019 TORONTO, ONTARIO M9L 1T9 CONTROL NUMBER: 223805 _APO-PERINDOPRIL ARGININE PRODUCT MONOGRAPH _ _Page 2 of 68_ _ _ 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 ......................................................................................................... 14 DRUG INTERACTIONS ......................................................................................................... 21 DOSAGE AND ADMINISTRATION ..................................................................................... 25 OVERDOSAGE ........................................................................................................................ 27 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 28 STORAGE AND STABILITY ................................................................................................. 32 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 32 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 32 PART II: SCIENTIFIC INFORMATION ............................................................................... 34 PHARMACEUTICAL INFORM Les hele dokumentet