M-PERINDOPRIL ERBUMINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PERINDOPRIL ERBUMINE

Tersedia dari:

MANTRA PHARMA INC

Kode ATC:

C09AA04

INN (Nama Internasional):

PERINDOPRIL

Dosis:

4MG

Bentuk farmasi:

TABLET

Komposisi:

PERINDOPRIL ERBUMINE 4MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0127178002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-11-16

Karakteristik produk

_M-PERINDOPRIL ERBUMINE (Perindopril Erbumine Tablets) Product
Monograph _
_ _
_ _
_Page 1 of 74_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
M-PERINDOPRIL ERBUMINE
Perindopril Erbumine Tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
USP
Angiotensin Converting Enzyme Inhibitor
Mantra Pharma Inc.
1000 rue Du Lux, Suite 201
Brossard, Quebec
J4Y 0E3
Submission Control Number: 277654
Date of Initial Authorization:
NOV 16, 2018
Date of Revision:
AUG
18, 2023
_M-PERINDOPRIL ERBUMINE (Perindopril Erbumine Tablets) Product
Monograph _
_ _
_ _
_Page 2 of 74_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2023
7 WARNINGS AND PRECAUTIONS
08/2023
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
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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)
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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 Adjustment
......................................................