APO-PERINDOPRIL-INDAPAMIDE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

INDAPAMIDE; PERINDOPRIL ERBUMINE

Disponibil de la:

APOTEX INC

Codul ATC:

C09BA04

INN (nume internaţional):

PERINDOPRIL AND DIURETICS

Dozare:

0.625MG; 2MG

Forma farmaceutică:

TABLET

Compoziție:

INDAPAMIDE 0.625MG; PERINDOPRIL ERBUMINE 2MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0248401002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-03-07

Caracteristicilor produsului

_APO-PERINDOPRIL-INDAPAMIDE (Perindopril Erbumine and Indapamide
Tablets) _
_Page 1 of 79_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-PERINDOPRIL-INDAPAMIDE
Perindopril Erbumine and Indapamide Tablets
Tablets, 2 mg / 0.625 mg, 4 mg / 1.25 mg and 8 mg / 2.5 mg, Oral
Angiotensin converting enzyme inhibitor / Diuretic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAR 07, 2018
Date of Revision:
MAY 09, 2023
Submission Control Number: 271176
_APO-PERINDOPRIL-INDAPAMIDE (Perindopril Erbumine and Indapamide
Tablets) _
_Page 2 of 79_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
05/2023
7 WARNINGS AND PRECAUTIONS
05/2023
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
....................................................................................
6
4.1
Dosing Considerations
...................................................................................................
6
4.2
Recommended Dose and Dosage
Adjustme