MYLAN-CANDESARTAN HCTZ TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

C09DA06

INN (Nama Antarabangsa):

CANDERSARTAN AND DIURETICS

Dos:

16.0MG; 12.5MG

Borang farmaseutikal:

TABLET

Komposisi:

CANDESARTAN CILEXETIL 16.0MG; HYDROCHLOROTHIAZIDE 12.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0244181001; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2017-01-11

Ciri produk

PAGE 1 OF 45
PRODUCT MONOGRAPH
PR
MYLAN-CANDESARTAN HCTZ
Candesartan Cilexetil/Hydrochlorothiazide Tablets
16 mg / 12.5 mg, 32 mg / 12.5 mg and 32 mg / 25 mg
Angiotensin II AT
1
Receptor Blocker + Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: April 18, 2016
Submission Control No.: 193747
PAGE 2 OF 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS
AND
PRECAUTIONS
.........................................................................................
5
ADVERSE
REACTIONS
.........................................................................................................
10
DRUG
INTERACTIONS
.........................................................................................................
15
DOSAGE
AND
ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
23
STORAGE
AND
STABILITY
.................................................................................................
26
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
28
PHARMACEUTICAL
INFORMATION
.................................................................................
28
CLINICAL
TRIALS
........................................