País: Canadá
Idioma: inglés
Fuente: Health Canada
CETIRIZINE HYDROCHLORIDE
VITA HEALTH PRODUCTS INC
R06AE07
CETIRIZINE
20MG
TABLET
CETIRIZINE HYDROCHLORIDE 20MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0122686003; AHFS:
APPROVED
2022-12-01
Pr Cetitrizine Hydrochloride Tablets Page 1 of 31 PRODUCT MONOGRAPH PR CETIRIZINE HYDROCHLORIDE TABLETS 20MG MFR. STD. Histamine H 1 Receptor Antagonist Vita Health Products Inc. Date of Preparation: 150 Beghin Avenue November 29, 2022 Winnipeg, MB R2J 3W2 Control Number: 264926 Pr Cetitrizine Hydrochloride Tablets Page 2 of 31 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 ................................................................................. 12 CLINICAL TRIALS .............................................. Leer el documento completo