MYLAN-IRBESARTAN HCTZ TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Saatavilla:

MYLAN PHARMACEUTICALS ULC

ATC-koodi:

C09DA04

INN (Kansainvälinen yleisnimi):

IRBESARTAN AND DIURETICS

Annos:

300MG; 25MG

Lääkemuoto:

TABLET

Koostumus:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG

Antoreitti:

ORAL

Kpl paketissa:

90

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0240086003; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2016-11-02

Valmisteyhteenveto

1
PRODUCT MONOGRAPH
PR MYLAN-IRBESARTAN HCTZ
Irbesartan and Hydrochlorothiazide Tablets
150/12.5 mg, 300/12.5 mg and 300/25 mg
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 189365
Date of Revision: November 24, 2015
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
.................................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
.................................................................................
27
CLINICAL TRIALS
.......................................................