NRA-CETIRIZINE TABLETS

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CETIRIZINE HYDROCHLORIDE

متاح من:

NORA PHARMA INC

ATC رمز:

R06AE07

INN (الاسم الدولي):

CETIRIZINE

جرعة:

20MG

الشكل الصيدلاني:

TABLET

تركيب:

CETIRIZINE HYDROCHLORIDE 20MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

ملخص المنتج:

Active ingredient group (AIG) number: 0122686003; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2022-08-30

خصائص المنتج

Page 1 of 32
PRODUCT MONOGRAPH
PR
NRA-CETIRIZINE TABLETS
CETIRIZINE HYDROCHLORIDE TABLETS
20 MG
Histamine H
1
Receptor Antagonist
Nora Pharma Inc.
Date of Revision:
1565, Boul. Lionel-Boulet
August 24, 2022
Varennes, Quebec
J3X1P7
Control # 266426
Page 2 of 32
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
3
SUMMARY PRODUCT INFORMATION
.............................................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................................
3
CONTRAINDICATIONS
........................................................................................................................
3
WARNINGS AND PRECAUTIONS
......................................................................................................
3
ADVERSE REACTIONS
........................................................................................................................
5
DRUG INTERACTIONS
.........................................................................................................................
7
DOSAGE AND ADMINISTRATION
.....................................................................................................
7
OVERDOSAGE
.......................................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
...................................................................................
9
STORAGE AND STABILITY
..............................................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................. 10
PART II: SCIENTIFIC INFORMATION
..................................................................................................
12
PHARMACEUTICAL INFORMATION
....................................