Land: Kanada
Tungumál: enska
Heimild: Health Canada
CITALOPRAM (CITALOPRAM HYDROBROMIDE)
MARCAN PHARMACEUTICALS INC
N06AB04
CITALOPRAM
10MG
TABLET
CITALOPRAM (CITALOPRAM HYDROBROMIDE) 10MG
ORAL
100/1000
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0136243003; AHFS:
APPROVED
2016-11-17
_IPG-CITALOPRAM (_ _citalopram hydrobromide) Product Monograph _ _Page 1 of 45 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR IPG-CITALOPRAM ® Citalopram tablets Tablets, 10, 20 and 40 mg citalopram (as citalopram hydrobromide), Oral USP Antidepressant Marcan Pharmaceuticals Inc. 2 Gurdwara Road, Suite #112, Ottawa, Ontario Canada, K2E 1A2 Date of Initial Authorization: NOV 17, 2016 Date of Revision: July 29, 2022 Submission Control Number: 261614 _IPG-CITALOPRAM (_ _citalopram hydrobromide) Product Monograph _ _Page 2 of 45 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Hematologic 07/2022 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 07/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 07/2022 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 INFORM ATION ...................................................... 4 1 INDICATIONS .......................................................................................................... 4 1.1 Pediatrics ......................................................................................................... 4 1.2 Geriatrics ......................................................................................................... 4 2 CONTRAINDICATIONS .......................................................................................... 4 4 DOSAGE AND ADMINISTRATION ........................................................................ 5 4.1 Dosing Considerations .................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ............................................. 6 4.4 Administration................................... Lestu allt skjalið