SEPTA-CANDESARTAN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CANDESARTAN CILEXETIL

Disponible depuis:

SEPTA PHARMACEUTICALS INC

Code ATC:

C09CA06

DCI (Dénomination commune internationale):

CANDESARTAN

Dosage:

32MG

forme pharmaceutique:

TABLET

Composition:

CANDESARTAN CILEXETIL 32MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-10-20

Résumé des caractéristiques du produit

_SEPTA-CANDESARTAN – Product Monograph _
_ Page 1 of 30_
PRODUCT MONOGRAPH
Pr
SEPTA-CANDESARTAN
candesartan cilexetil tablets
16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Septa Pharmaceuticals Inc.
7490 Pacific Circle, Unit # 1
Mississauga, ON L5T 2A3
Canada
Date of Preparation:
October 16, 2015
SUBMISSION CONTROL NO: 187806
_ _
_SEPTA-CANDESARTAN – Product Monograph Page 2 of 30 _
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE…………………………………………………………………………16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL INFORMATION
..........................................................................20
CLINICAL TRIALS
..........................................................................................................21
DETAILED PHARMACOLOGY
.....................................................................................23
TOXICOLOGY
......................