Страна: Канада
Език: английски
Източник: Health Canada
LORAZEPAM
TEVA CANADA LIMITED
N05BA06
LORAZEPAM
0.5MG
TABLET
LORAZEPAM 0.5MG
ORAL
100/500/1000
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0110731003; AHFS:
APPROVED
2013-12-06
TEVA-LORAZEPAM Page 1 of 33 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION TEVA-LORAZEPAM Lorazepam Tablets Tablets, 0.5 mg, 1 mg, 2 mg, Oral Teva Standard Anxiolytic-Sedative Teva Canada Limited 30 Novopharm Court Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Date of Initial Authorization: March 05, 1985 Date of Revision: March 24, 2023 Submission Control No.: 271985 TEVA-LORAZEPAM Page 2 of 33 RECENT MAJOR LABEL CHANGES 1 Indications 03/2023 1 Indications, 1.2 Geriatrics 12/2021 3 Serious Warnings and Precautions Box 12/2021 4 Dosage and Administration, 4.1 Dosing Considerations 12/2021 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 03/2023 7 Warnings and Precautions 03/2023 7 Warnings and Precautions, 7.1.4 Geriatrics 12/2021 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 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................................ 4 4 DOSAGE AND ADMINISTRATION………………………………… Прочетете целия документ