CANDESARTAN TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CANDESARTAN CILEXETIL

Tilgjengelig fra:

SANIS HEALTH INC

ATC-kode:

C09CA06

INN (International Name):

CANDESARTAN

Dosering :

4MG

Legemiddelform:

TABLET

Sammensetning:

CANDESARTAN CILEXETIL 4MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2012-07-18

Preparatomtale

_ _
_Page 1 of 35_
_CANDESARTAN_
PRODUCT MONOGRAPH
PR
CANDESARTAN
Candesartan Cilexetil Tablets
4 mg, 8 mg, 16 mg and 32 mg
Manufacturer's Standard
Angiotensin II AT
1
Receptor Blocker
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control No.: 263148
Date of
Revision:
May
13, 2022
_ _
_CANDESARTAN _
_Page 2 of 35_
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
...........................................................................................................
12
DOSAGE
AND
ADMINISTRATION
.......................................................................................
14
OVERDOSAGE
.........................................................................................................................
17
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
17
STORAGE
AND
STABILITY...................................................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 19
PART II: SCIENTIFIC INFORMATION
................................................................................
21
PHARMACEUTICAL
INFORMATION
..................................................................................
21
CLINICAL
TRIALS
..............