MYLAN-IRBESARTAN HCTZ TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

IRBESARTAN; HYDROCHLOROTHIAZIDE

から入手可能:

MYLAN PHARMACEUTICALS ULC

ATCコード:

C09DA04

INN（国際名）:

IRBESARTAN AND DIURETICS

投薬量:

300MG; 12.5MG

医薬品形態:

TABLET

構図:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 12.5MG

投与経路:

ORAL

パッケージ内のユニット:

90/500

処方タイプ:

Prescription

治療領域:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

製品概要:

Active ingredient group (AIG) number: 0240086002; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2016-11-02

製品の特徴

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