SEPTA-CANDESARTAN TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

CANDESARTAN CILEXETIL

Dostupné z:

SEPTA PHARMACEUTICALS INC

ATC kód:

C09CA06

INN (Medzinárodný Name):

CANDESARTAN

Dávkovanie:

16MG

Forma lieku:

TABLET

Zloženie:

CANDESARTAN CILEXETIL 16MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2015-10-20

Súhrn charakteristických

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