JAMP-IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

اشتر الآن

تأكيد الحساب خصائص المنتج (SPC)
02-01-2014

العنصر النشط:

IRBESARTAN; HYDROCHLOROTHIAZIDE

متاح من:

JAMP PHARMA CORPORATION

ATC رمز:

C09DA04

INN (الاسم الدولي):

IRBESARTAN AND DIURETICS

جرعة:

150MG; 12.5MG

الشكل الصيدلاني:

TABLET

تركيب:

IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

28/100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

ملخص المنتج:

Active ingredient group (AIG) number: 0240086001; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2022-09-06

خصائص المنتج

                                _Jamp-Irbesartan and Hydrochlorothiazide _
_Page 1 of 40_
PRODUCT MONOGRAPH
PR
JAMP-IRBESARTAN AND HYDROCHLOROTHIAZIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
(House Standard)
150/12.5 mg, 300/12.5 mg and 300/25 mg
Angiotensin II AT
1
Receptor Blocker / Diuretic
JAMP PHARMA CORPORATION
DATE OF PREPARATION:
1380-203 NEWTON,
BOUCHERVILLE, QUÉBEC, J4B 5H2
December 11, 2013
SUBMISSION CONTROL NO.: 170093
_Jamp-Irbesartan and Hydrochlorothiazide _
_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
..............................................................................................................
9
DRUG INTERACTIONS
............................................................................................................
13
DOSAGE AND ADMINISTRATION
........................................................................................
16
OVERDOSAGE
...........................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
19
STORAGE AND STABILITY
....................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 22
PART II: SCIENTIFIC INFORMATION
.......................................................................................

                                
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