CANDESARTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CANDESARTAN CILEXETIL

Tersedia dari:

RANBAXY PHARMACEUTICALS CANADA INC.

Kode ATC:

C09CA06

INN (Nama Internasional):

CANDESARTAN

Dosis:

16MG

Bentuk farmasi:

TABLET

Komposisi:

CANDESARTAN CILEXETIL 16MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2013-08-21

Karakteristik produk

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_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
.....................................................