ATACAND TAB 8MG TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CANDESARTAN CILEXETIL

Dostępny od:

ASTRAZENECA CANADA INC

Kod ATC:

C09CA06

INN (International Nazwa):

CANDESARTAN

Dawkowanie:

8MG

Forma farmaceutyczna:

TABLET

Skład:

CANDESARTAN CILEXETIL 8MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0135220002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2000-01-18

Charakterystyka produktu

COPYRIGHT 1998-2016 ASTRAZENECA CANADA INC.
Page 1 of 39
PRODUCT MONOGRAPH
ATACAND
®
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Revision:
February 19, 2016
Submission Control Number: 187873
ATACAND
®
is a registered trademark of the AstraZeneca group of companies.
Manufactured
under license from Takeda Pharmaceutical Company Ltd.
COPYRIGHT 1998-2016 ASTRAZENECA CANADA INC.
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
...............................................................................
5
ADVERSE REACTIONS
.................................................................................................
9
DRUG INTERACTIONS
...............................................................................................
15
DOSAGE AND ADMINISTRATION
...........................................................................
19
OVERDOSAGE
..............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 22
STORAGE AND STABILITY
.......................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 25
PART II: SCIENTIFIC INFORMATION
.............................................................................
26
PHARMACEUTICAL INFORMATION
.......................................................