Land: Kanada
Sprache: Englisch
Quelle: Health Canada
PERINDOPRIL ERBUMINE; INDAPAMIDE
SANDOZ CANADA INCORPORATED
C09BA04
PERINDOPRIL AND DIURETICS
2MG; 0.625MG
TABLET
PERINDOPRIL ERBUMINE 2MG; INDAPAMIDE 0.625MG
ORAL
30
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0248401002; AHFS:
APPROVED
2017-12-12
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr SANDOZ ® PERINDOPRIL ERBUMINE / INDAPAMIDE LD 2 mg / 0.625 mg tablets Pr SANDOZ ® PERINDOPRIL ERBUMINE / INDAPAMIDE 4 mg / 1.25 mg tablets Pr SANDOZ ® PERINDOPRIL ERBUMINE / INDAPAMIDE HD 8 mg / 2.5 mg tablets (perindopril erbumine / indapamide) Angiotensin Converting Enzyme Inhibitor / Diuretic Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, QC, Canada J4B 1E6 Date of Initial Authorization: December 12, 2017 Date of Revision: May 24, 2023 Submission Control No.: 270365 _ _ _Sandoz Perindopril Erbumine / Indapamide LD, _ _Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD _ _Page 2 of 76_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 05/2023 7 WARNING 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 ....................................................................... 3 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 ....................................... Lesen Sie das vollständige Dokument