Riik: Kanada
keel: inglise
Allikas: Health Canada
PERINDOPRIL ERBUMINE; INDAPAMIDE
APOTEX INC
C09BA04
PERINDOPRIL AND DIURETICS
4MG; 1.25MG
TABLET
PERINDOPRIL ERBUMINE 4MG; INDAPAMIDE 1.25MG
ORAL
15G/50G
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0248401001; AHFS:
APPROVED
2018-03-07
_APO-PERINDOPRIL-INDAPAMIDE (Perindopril Erbumine and Indapamide Tablets) _ _Page 1 of 79_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-PERINDOPRIL-INDAPAMIDE Perindopril Erbumine and Indapamide Tablets Tablets, 2 mg / 0.625 mg, 4 mg / 1.25 mg and 8 mg / 2.5 mg, Oral Angiotensin converting enzyme inhibitor / Diuretic APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: MAR 07, 2018 Date of Revision: MAY 09, 2023 Submission Control Number: 271176 _APO-PERINDOPRIL-INDAPAMIDE (Perindopril Erbumine and Indapamide Tablets) _ _Page 2 of 79_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 05/2023 7 WARNINGS AND PRECAUTIONS 05/2023 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 .................................................................................... 6 4.1 Dosing Considerations ................................................................................................... 6 4.2 Recommended Dose and Dosage Adjustme Lugege kogu dokumenti