AURO-CANDESARTAN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CANDESARTAN CILEXETIL

Disponible depuis:

AURO PHARMA INC

Code ATC:

C09CA06

DCI (Dénomination commune internationale):

CANDESARTAN

Dosage:

4MG

forme pharmaceutique:

TABLET

Composition:

CANDESARTAN CILEXETIL 4MG

Mode d'administration:

ORAL

Unités en paquet:

30/90/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-09-18

Résumé des caractéristiques du produit

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
......................