NRA-CETIRIZINE TABLETS
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
24-08-2022
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Aktiv ingrediens:
CETIRIZINE HYDROCHLORIDE
Tilgjengelig fra:
NORA PHARMA INC
ATC-kode:
R06AE07
INN (International Name):
CETIRIZINE
Dosering :
20MG
Legemiddelform:
TABLET
Sammensetning:
CETIRIZINE HYDROCHLORIDE 20MG
Administreringsrute:
ORAL
Enheter i pakken:
15G/50G
Resept typen:
Prescription
Produkt oppsummering:
Active ingredient group (AIG) number: 0122686003; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2022-08-30
Preparatomtale
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
....................................
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