Land: Kanada
Sprache: Englisch
Quelle: Health Canada
PERINDOPRIL ARGININE; AMLODIPINE (AMLODIPINE BESYLATE)
APOTEX INC
C09BB04
PERINDOPRIL AND AMLODIPINE
3.5MG; 2.5MG
TABLET
PERINDOPRIL ARGININE 3.5MG; AMLODIPINE (AMLODIPINE BESYLATE) 2.5MG
ORAL
30/100/500
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0257790001; AHFS:
APPROVED
2019-05-09
_APO-PERINDOPRIL/AMLODIPINE (Perindopril arginine and Amlodipine) _ _Page 1 of 62 _ _ _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-PERINDOPRIL/AMLODIPINE Perindopril Arginine and Amlodipine Tablets Tablets, 3.5 mg Perindopril arginine / 2.5 mg Amlodipine (as amlodipine besylate), Oral Tablets, 7 mg Perindopril arginine / 5 mg Amlodipine (as amlodipine besylate), Oral Tablets, 14 mg Perindopril arginine / 10 mg Amlodipine (as amlodipine besylate), Oral Angiotensin converting enzyme inhibitor / Dihydropyridine calcium antagonist APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: MAY 09, 2019 Date of Revision: OCT 11, 2023 Submission Control Number: 275887 _APO-PERINDOPRIL/AMLODIPINE (Perindopril arginine and Amlodipine) _ _Page 2 of 62 _ _ _ _ _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 10/2023 7 WARNING AND PRECAUTIONS 10/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 4 1 INDICATIONS .................................................................................................................... 4 1.1 Pediatrics (<18 years of age) ......................................................................................... 4 1.2 Geriatrics (> 65 years of age) ........................................................................................ 4 2 CONTRAINDICATIONS ....................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................. 5 4 DOSAGE AND ADMINISTRATION ................. Lesen Sie das vollständige Dokument