AURO-PERINDOPRIL TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

PERINDOPRIL ERBUMINE

Prieinama:

AURO PHARMA INC

ATC kodas:

C09AA04

INN (Tarptautinis Pavadinimas):

PERINDOPRIL

Dozė:

8MG

Vaisto forma:

TABLET

Sudėtis:

PERINDOPRIL ERBUMINE 8MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100/500

Recepto tipas:

Prescription

Gydymo sritis:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2018-03-07

Prekės savybės

AURO-PERINDOPRIL PRODUCT MONOGRAPH Page 1 of 67
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-PERINDOPRIL
Perindopril Erbumine Tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
House Standard
Angiotensin Converting Enzyme Inhibitor
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Initial Authorization:
January 11, 2018
Date of Revision:
June 6, 2023
Submission Control Number: 270817
AURO-PERINDOPRIL PRODUCT MONOGRAPH Page 2 of 67
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2023
7 WARNING AND PRECAUTIONS
06/2023
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
.........................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................................... 5
4 DOSAGE AND ADMINISTRATION
........................................................................................
5
4.1 Dosing Considerations
...............................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
............................................................ 6
4.4 Administration