TARO-CANDESARTAN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CANDESARTAN CILEXETIL

Доступно од:

SUN PHARMA CANADA 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:

2020-03-04

Карактеристике производа

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_PR_
_TARO-CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
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_Page 1 of 39_
PRODUCT MONOGRAPH
PR
TARO–CANDESARTAN
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Sun Pharma Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
Date of Revision:
March 2, 2020
Submission Control Number: 236155
_ _
_PR_
_TARO-CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
_ _
_Page 2 of 39_
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
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
....................................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
......................................................