TEVA-CANDESARTAN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CANDESARTAN CILEXETIL

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

C09CA06

DCI (Dénomination commune internationale):

CANDESARTAN

Dosage:

32MG

forme pharmaceutique:

TABLET

Composition:

CANDESARTAN CILEXETIL 32MG

Mode d'administration:

ORAL

Unités en paquet:

30

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:

2012-02-10

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
TEVA-CANDESARTAN
Candesartan cilexetil Tablets
8 mg, 16 mg, and 32 mg
Angiotensin II AT
1
Receptor Blocker
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No. 194121
Date of Revision:
May 2, 2016
2
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
.....................................................................................
13
DOSAGE AND ADMINISTRATION
................................................................. 15
OVERDOSAGE
...................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................... 18
STORAGE AND STABILITY
.............................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 20
PART II: SCIENTIFIC INFORMATION
....................................................................................
22
PHARMACEUTICAL INFORMATION
............................................................. 22
CLINICAL TRIALS
.............................................................................................
23
DETAILED PHARMACOLOGY
........................................................................
26
TOXICOLOGY
....................................................................................................
26
REFERENCES
.......................................................