MYLAN-CANDESARTAN HCTZ TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Mevcut itibaren:

MYLAN PHARMACEUTICALS ULC

ATC kodu:

C09DA06

INN (International Adı):

CANDERSARTAN AND DIURETICS

Doz:

32.0MG; 25.0MG

Farmasötik formu:

TABLET

Kompozisyon:

CANDESARTAN CILEXETIL 32.0MG; HYDROCHLOROTHIAZIDE 25.0MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ürün özeti:

Active ingredient group (AIG) number: 0244181003; AHFS:

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2017-01-11

Ürün özellikleri

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
........................................