RAN-IRBESARTAN HCTZ TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

IRBESARTAN; HYDROCHLOROTHIAZIDE

متاح من:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC رمز:

C09DA04

INN (الاسم الدولي):

IRBESARTAN AND DIURETICS

جرعة:

300MG; 12.5MG

الشكل الصيدلاني:

TABLET

تركيب:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 12.5MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

ملخص المنتج:

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

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2022-07-12

خصائص المنتج

_ _
_RAN-Irbesartan HCTZ _
_Page 1 of 40_
PRODUCT MONOGRAPH
PR
RAN™-IRBESARTAN HCTZ
IRBESARTAN/HYDROCHLOROTHIAZIDE
TABLETS, 150/12.5 MG, 300/12.5 MG AND 300/25 MG
HOUSE STANDARD
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER / DIURETIC
Ranbaxy Pharmaceuticals Canada Inc.
Date of Revision:
126 East Drive December 7, 2018
Brampton, Ontario
L6T 1C1
SUBMISSION CONTROL NO.: 222307
_ _
_RAN-Irbesartan HCTZ _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT
INFORMATION.................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
3
CONTRAINDICATIONS
............................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................
4
ADVERSE REACTIONS
............................................................................................................
8
DRUG
INTERACTIONS...........................................................................................................
13
DOSAGE AND ADMINISTRATION
......................................................................................
18
OVERDOSAGE
.........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
20
STORAGE AND STABILITY
..................................................................................................
23
DOSAGE FORMS, COMPOSITION AND
PACKAGING...................................................... 23
PART II: SCIENTIFIC
INFORMATION.................................................................................
24
PHARMACEUTICAL INFORMATION
.............................................................