MYLAN-CANDESARTAN TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CANDESARTAN CILEXETIL

Beschikbaar vanaf:

MYLAN PHARMACEUTICALS ULC

ATC-code:

C09CA06

INN (Algemene Internationale Benaming):

CANDESARTAN

Dosering:

16MG

farmaceutische vorm:

TABLET

Samenstelling:

CANDESARTAN CILEXETIL 16MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/100

Prescription-type:

Prescription

Therapeutisch gebied:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product samenvatting:

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

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2018-08-03

Productkenmerken

_MYLAN-CANDESARTAN Product Monograph_
_Page 1 of 38 _
PRODUCT MONOGRAPH
PR
MYLAN-CANDESARTAN
(candesartan cilexetil tablets)
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Mylan Pharmaceuticals ULC
85 Advance Road
Toronto, ON
M8Z 2S6
Submission Control Number: 193792
Date of Preparation: December 4, 2009
Date of Revision:
April 14, 2016
_MYLAN-CANDESARTAN Product Monograph_
_Page 2 of 38 _
TABLE OF CONTENTS
PART 1: HEALTH PROFESSIONAL INFORMATION .................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
........................................................................................
4
ADVERSE REACTIONS
..........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
....................................................................................
17
OVERDOSAGE
.........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
20
STORAGE AND STABILITY
................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 22
PART II: SCIENTIFIC INFORMATION .............................................................................
24
PHARMACEUTICAL INFORMATION
...............................................................................
24
CLINICAL T