TEVA-CANDESARTAN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CANDESARTAN CILEXETIL

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

C09CA06

INN (Међународно име):

CANDESARTAN

Дозирање:

32MG

Фармацеутски облик:

TABLET

Састав:

CANDESARTAN CILEXETIL 32MG

Пут администрације:

ORAL

Јединице у пакету:

30

Тип рецептора:

Prescription

Терапеутска област:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Резиме производа:

Active ingredient group (AIG) number: 0135220004; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2012-02-10

Карактеристике производа

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
.......................................................