AURO-PERINDOPRIL TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PERINDOPRIL ERBUMINE

Dostopno od:

AURO PHARMA INC

Koda artikla:

C09AA04

INN (mednarodno ime):

PERINDOPRIL

Odmerek:

8MG

Farmacevtska oblika:

TABLET

Sestava:

PERINDOPRIL ERBUMINE 8MG

Pot uporabe:

ORAL

Enote v paketu:

30/100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2018-03-07

Lastnosti izdelka

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