APO-PERINDOPRIL/AMLODIPINE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PERINDOPRIL ARGININE; AMLODIPINE (AMLODIPINE BESYLATE)

Mevcut itibaren:

APOTEX INC

ATC kodu:

C09BB04

INN (International Adı):

PERINDOPRIL AND AMLODIPINE

Doz:

14MG; 10MG

Farmasötik formu:

TABLET

Kompozisyon:

PERINDOPRIL ARGININE 14MG; AMLODIPINE (AMLODIPINE BESYLATE) 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100/500

Reçete türü:

Prescription

Terapötik alanı:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0257790003; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2019-05-09

Ürün özellikleri

_APO-PERINDOPRIL/AMLODIPINE (Perindopril arginine and Amlodipine) _
_Page 1 of 62 _
_ _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-PERINDOPRIL/AMLODIPINE
Perindopril Arginine and Amlodipine Tablets
Tablets, 3.5 mg Perindopril arginine / 2.5 mg Amlodipine (as
amlodipine besylate), Oral
Tablets, 7 mg Perindopril arginine / 5 mg Amlodipine (as amlodipine
besylate), Oral
Tablets, 14 mg Perindopril arginine / 10 mg Amlodipine (as amlodipine
besylate), Oral
Angiotensin converting enzyme inhibitor / Dihydropyridine calcium
antagonist
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 09, 2019
Date of Revision:
OCT 11, 2023
Submission Control Number: 275887
_APO-PERINDOPRIL/AMLODIPINE (Perindopril arginine and Amlodipine) _
_Page 2 of 62 _
_ _
_ _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2023
7 WARNING AND PRECAUTIONS
10/2023
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
.................