AURO-CANDESARTAN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CANDESARTAN CILEXETIL

Boleh didapati daripada:

AURO PHARMA INC

Kod ATC:

C09CA06

INN (Nama Antarabangsa):

CANDESARTAN

Dos:

8MG

Borang farmaseutikal:

TABLET

Komposisi:

CANDESARTAN CILEXETIL 8MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/90/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0135220002; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2015-09-18

Ciri produk

Page 1 of 36
PRODUCT MONOGRAPH
PR
AURO-CANDESARTAN
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
House standard
Angiotensin II AT
1
Receptor Blocker
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402
September 27, 2018
Woodbridge, Ontario, L4L 8K8
CANADA
Submission Control No: 211944
Page 2 of 36
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
......................