NRA-CETIRIZINE TABLETS
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
24-08-2022
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Aktiva substanser:
CETIRIZINE HYDROCHLORIDE
Tillgänglig från:
NORA PHARMA INC
ATC-kod:
R06AE07
INN (International namn):
CETIRIZINE
Dos:
20MG
Läkemedelsform:
TABLET
Sammansättning:
CETIRIZINE HYDROCHLORIDE 20MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Produktsammanfattning:
Active ingredient group (AIG) number: 0122686003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2022-08-30
Produktens egenskaper
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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