MINT-CANDESARTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CANDESARTAN CILEXETIL

Tersedia dari:

MINT PHARMACEUTICALS INC

Kode ATC:

C09CA06

INN (Nama Internasional):

CANDESARTAN

Dosis:

32MG

Bentuk farmasi:

TABLET

Komposisi:

CANDESARTAN CILEXETIL 32MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100/1000

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0135220004; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-06-05

Karakteristik produk

MINT-CANDESARTAN Product Monograph
Page 1 of 34
PRODUCT MONOGRAPH
PR
MINT-CANDESARTAN
Candesartan Cilexetil Tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Mint Pharmaceuticals Inc., DATE OF REVISION:
6575 Davand Drive
November 29, 2022
Mississauga, Ontario
L5T 2M3
Submission
Control No: 265629
MINT-CANDESARTAN Product Monograph
Page 2 of 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...........................................................
3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL
USE................................................................................
3
CONTRAINDICATIONS
....................................................................................................
3
WARNINGS AND PRECAUTIONS
...................................................................................
4
ADVERSE REACTIONS
....................................................................................................
8
DRUG
INTERACTIONS....................................................................................................13
DOSAGE AND
ADMINISTRATION.................................................................................14
OVERDOSAGE
.................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
................................................................17
STORAGE AND
STABILITY............................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................20
PART II: SCIENTIFIC
INFORMATION................................................................................21
PHARMACEUTICAL
INFORMATION.............................................................................21
CLINICAL TRIALS
..........................................................................................