SEPTA-CANDESARTAN HCTZ TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

HYDROCHLOROTHIAZIDE; CANDESARTAN CILEXETIL

Saatavilla:

SEPTA PHARMACEUTICALS INC

ATC-koodi:

C09DA06

INN (Kansainvälinen yleisnimi):

CANDERSARTAN AND DIURETICS

Annos:

25MG; 32MG

Lääkemuoto:

TABLET

Koostumus:

HYDROCHLOROTHIAZIDE 25MG; CANDESARTAN CILEXETIL 32MG

Antoreitti:

ORAL

Kpl paketissa:

30/80/1000

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0244181003; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2015-04-29

Valmisteyhteenveto

Page 1 of 38
_Septa-Candesartan HCTZ_
PRODUCT
MONOGRAPH
PR
SEPTA-CANDESARTAN HCTZ
CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE TABLETS
32 MG / 12.5 MG,
32 MG / 25 MG
ANGIOTENSIN II AT1 RECEPTOR BLOCKER + DIURETIC
Septa Pharmaceuticals Inc
Date of Preparation:
7490 Pacific Circle, # 1
April 22, 2015
Mississauga, ON L5T 2A3
Canada
Submission Control Number : 183582
Page 2 of 38
_Septa-Candesartan HCTZ_
TABLE OF CONTENTS
CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................................
3
CONTRAINDICATIONS
.................................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................................
4
ADVERSE REACTIONS
.................................................................................................................
9
DRUG INTERACTIONS
...............................................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................................
18
OVERDOSAGE
..............................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
20
STORAGE AND STABILITY
.......................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 24
PART II: SCIENTIFIC INFORMATION
...................................................................................................................
25
PHARMACEUTICAL INFORMATION
..................................................