MYLAN-IRBESARTAN HCTZ TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

IRBESARTAN; HYDROCHLOROTHIAZIDE

제공처:

MYLAN PHARMACEUTICALS ULC

ATC 코드:

C09DA04

INN (International Name):

IRBESARTAN AND DIURETICS

복용량:

300MG; 12.5MG

약제 형태:

TABLET

구성:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 12.5MG

관리 경로:

ORAL

패키지 단위:

90/500

처방전 유형:

Prescription

치료 영역:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

제품 요약:

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

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2016-11-02

제품 특성 요약

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