MYLAN-CANDESARTAN HCTZ TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

C09DA06

INN (International Name):

CANDERSARTAN AND DIURETICS

Dosering :

32.0MG; 25.0MG

Legemiddelform:

TABLET

Sammensetning:

CANDESARTAN CILEXETIL 32.0MG; HYDROCHLOROTHIAZIDE 25.0MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2017-01-11

Preparatomtale

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