SEPTA-CANDESARTAN TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CANDESARTAN CILEXETIL

Доступно од:

SEPTA PHARMACEUTICALS INC

АТЦ код:

C09CA06

INN (Међународно име):

CANDESARTAN

Дозирање:

16MG

Фармацеутски облик:

TABLET

Састав:

CANDESARTAN CILEXETIL 16MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2015-10-20

Карактеристике производа

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