NRA-CETIRIZINE TABLETS

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CETIRIZINE HYDROCHLORIDE

Disponible desde:

NORA PHARMA INC

Código ATC:

R06AE07

Designación común internacional (DCI):

CETIRIZINE

Dosis:

20MG

formulario farmacéutico:

TABLET

Composición:

CETIRIZINE HYDROCHLORIDE 20MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2022-08-30

Ficha técnica

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