NRA-CETIRIZINE TABLETS
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
24-08-2022
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Werkstoffen:
CETIRIZINE HYDROCHLORIDE
Beschikbaar vanaf:
NORA PHARMA INC
ATC-code:
R06AE07
INN (Algemene Internationale Benaming):
CETIRIZINE
Dosering:
20MG
farmaceutische vorm:
TABLET
Samenstelling:
CETIRIZINE HYDROCHLORIDE 20MG
Toedieningsweg:
ORAL
Eenheden in pakket:
15G/50G
Prescription-type:
Prescription
Product samenvatting:
Active ingredient group (AIG) number: 0122686003; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2022-08-30
Productkenmerken
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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