Land: Kanada
Språk: engelska
Källa: Health Canada
CETIRIZINE HYDROCHLORIDE
JAMP PHARMA CORPORATION
R06AE07
CETIRIZINE
10MG
TABLET
CETIRIZINE HYDROCHLORIDE 10MG
ORAL
100/500
OTC
SECOND GENERATION ANTIHISTAMINES
Active ingredient group (AIG) number: 0122686001; AHFS:
APPROVED
2016-02-19
JAMP-Cetirizine - Product Monograph Page 1 of 34 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION JAMP-CETIRIZINE Cetirizine Hydrochloride Tablets Tablets, 5 mg, 10 mg, Oral Histamine H 1 Receptor Antagonist JAMP Pharma Corporation 1310 rue Nobel, Boucherville, Quebec J4B 5H3, Canada Date of Initial Authorization: February 19, 2016 Date of Revision: June 09, 2023 Submission Control Number: 274964 JAMP-Cetirizine - Product Monograph Page 2 of 34 RECENT MAJOR LABEL CHANGES N/A TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . RECENT MAJOR LABEL CHANGES .............................................................................................2 TABLE OF CONTENTS ...............................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................4 1 INDICATIONS ...............................................................................................................4 1.1 Pediatrics ...........................................................................................................4 1.2 Geriatrics............................................................................................................4 2 CONTRAINDICATIONS ..................................................................................................4 4 DOSAGE AND ADMINISTRATION ..................................................................................4 4.1 Dosing Considerations.........................................................................................4 4.2 Recommended Dose and Dosage Adjustment......................................................4 4.4 Administration....................................................................................................5 4.5 Missed Dose .......................................................................................................5 5 OVERDOSAGE ..... Läs hela dokumentet