SEPTA-CANDESARTAN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

CANDESARTAN CILEXETIL

Disponibbli minn:

SEPTA PHARMACEUTICALS INC

Kodiċi ATC:

C09CA06

INN (Isem Internazzjonali):

CANDESARTAN

Dożaġġ:

16MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

CANDESARTAN CILEXETIL 16MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0135220003; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2015-10-20

Karatteristiċi tal-prodott

_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
......................