MINT-PERINDOPRIL TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

PERINDOPRIL ERBUMINE

Tillgänglig från:

MINT PHARMACEUTICALS INC

ATC-kod:

C09AA04

INN (International namn):

PERINDOPRIL

Dos:

8MG

Läkemedelsform:

TABLET

Sammansättning:

PERINDOPRIL ERBUMINE 8MG

Administreringssätt:

ORAL

Enheter i paketet:

100/500

Receptbelagda typ:

Prescription

Terapiområde:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produktsammanfattning:

Active ingredient group (AIG) number: 0127178003; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2018-06-04

Produktens egenskaper

_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