APO-PERINDOPRIL-INDAPAMIDE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

INDAPAMIDE; PERINDOPRIL ERBUMINE

Mevcut itibaren:

APOTEX INC

ATC kodu:

C09BA04

INN (International Adı):

PERINDOPRIL AND DIURETICS

Doz:

2.5MG; 8MG

Farmasötik formu:

TABLET

Kompozisyon:

INDAPAMIDE 2.5MG; PERINDOPRIL ERBUMINE 8MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0248401003; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2018-03-07

Ürün özellikleri

_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