APO-CANDESARTAN TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CANDESARTAN CILEXETIL

MAH:

APOTEX INC

ATC_code:

C09CA06

INN:

CANDESARTAN

dosage:

4MG

pharmaceutical_form:

TABLET

composition:

CANDESARTAN CILEXETIL 4MG

administration_route:

ORAL

units_in_package:

10/100

prescription_type:

Prescription

therapeutic_area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0135220001; AHFS:

authorization_status:

APPROVED

authorization_date:

2011-04-26

SPC

_APO-CANDESARTAN Tablets Product Monograph_
Page 1 of 34
PRODUCT MONOGRAPH
PR
APO-CANDESARTAN
CANDESARTAN CILEXETIL TABLETS USP
4 MG, 8 MG, 16 MG AND 32 MG
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JANUARY 29, 2019
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 222632
_APO-CANDESARTAN Tablets 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
..........................................................................................................................
7_
_DRUG INTERACTIONS
.........................................................................................................................
13_
_DOSAGE AND ADMINISTRATION
.......................................................................................................
16_
_OVERDOSAGE
.....................................................................................................................................
18_
_ACTION AND CLINICAL PHARMACOLOGY
........................................................................................
18_
_STORAGE AND STABILITY
..................................................................................................................
21_
_DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................................
21_
PART II: SCIENTIFIC INFORMATION
..................