CANDESARTAN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CANDESARTAN CILEXETIL

זמין מ:

RANBAXY PHARMACEUTICALS CANADA INC.

קוד ATC:

C09CA06

INN (שם בינלאומי):

CANDESARTAN

כמות:

16MG

טופס פרצבטיות:

TABLET

הרכב:

CANDESARTAN CILEXETIL 16MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2013-08-21

מאפייני מוצר

_ _
_CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
PR
CANDESARTAN
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg, and 32 mg
Angiotensin II AT
1
Receptor Blocker
Ranbaxy Pharmaceuticals Canada Inc.,
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario L4W 0A5
Submission Control No: 166986
DATE OF PREPARATION:
August 15, 2013
_ _
_CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
_ _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
.....................................................