Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
PERINDOPRIL ERBUMINE
MINT PHARMACEUTICALS INC
C09AA04
PERINDOPRIL
2MG
TABLET
PERINDOPRIL ERBUMINE 2MG
ORAL
100/500
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0127178001; AHFS:
APPROVED
2018-06-04
_MINT-PERINDOPRIL (Perindopril Erbumine Tablets) Product Monograph_ _ _ _Page 1 of 64 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MINT-PERINDOPRIL Perindopril Erbumine Tablets Tablets, 2 mg, 4 mg and 8 mg, Oral USP Angiotensin Converting Enzyme Inhibitor Mint Pharmaceuticals Inc 6575 Davand Drive Mississauga, ON, L5T2M3 Canada Date of Initial Authorization: JUNE 04, 2018 Date of Revision: DEC 19, 2023 Submission Control Number: 278311 _MINT-PERINDOPRIL (Perindopril Erbumine Tablets) Product Monograph_ _ _ _Page 2 of 64 _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 12/2023 7 WARNINGS AND PRECAUTIONS 12/2023 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 ....................................................................................... 5 4.1 Dosing Considerations .............................................................................................................. 5 4.2 Recommended Do Přečtěte si celý dokument