Q-CANDESARTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CANDESARTAN CILEXETIL

Tersedia dari:

QD PHARMACEUTICALS ULC

Kode ATC:

C09CA06

INN (Nama Internasional):

CANDESARTAN

Dosis:

32MG

Bentuk farmasi:

TABLET

Komposisi:

CANDESARTAN CILEXETIL 32MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0135220004; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2015-08-21

Karakteristik produk

_Q-CANDESARTAN Product Monograph_
_Page 1 of 38 _
PRODUCT MONOGRAPH
PR
Q-CANDESARTAN
(candesartan cilexetil tablets)
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
QD Pharmaceuticals ULC
85 Advance Road
Toronto, ON
M8Z 2S6
Submission Control Number: 184370
Date of Revision:
May 20, 2015
_Q-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
................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 23
PART II: SCIENTIFIC INFORMATION .............................................................................
24
PHARMACEUTICAL INFORMATION
...............................................................................
24
CLINICAL TRIALS
..................................................