দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
LORAZEPAM
PFIZER CANADA ULC
N05BA06
LORAZEPAM
0.5MG
TABLET
LORAZEPAM 0.5MG
ORAL
100/500
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0110731003; AHFS:
APPROVED
2003-04-02
_Product Monograph _ _ _ _ATIVAN (lorazepam) _ _Page 1 of 32 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ATIVAN ® Lorazepam Tablets, 0.5 mg, 1 mg, 2 mg, Oral Tablets, 0.5 mg, 1 mg, 2 mg, Sublingual Anxiolytic-Sedative Pfizer Canada ULC 17,300 Trans Canada Highway Kirkland, QC H9J 2M5 Date of Initial Authorization: FEB 4, 1977 Date of Revision: DEC 28, 2022 Submission Control Number: 267182 ® T.M. Wyeth Pfizer Canada ULC, Licensee © Pfizer Canada ULC _ _ _Product Monograph _ _ _ _ATIVAN (lorazepam) _ _Page 2 of 32 _ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.2 Geriatrics 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dosage and Dosage Adjustment 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance 7 WARNINGS AND PRECAUTIONS, Withdrawal 7 WARNINGS AND PRECAUTIONS, Immune 7 WARNINGS AND PRECAUTIONS, Neurologic, Falls and Fractures 7 WARNINGS AND PRECAUTIONS, Risks from Concomitant use of Opioids and Benzodiazepines 7 WARNINGS AND PRECAUTIONS, 7.1. Special Populations, 7.1.3 Pediatrics 7 WARNINGS AND PRECAUTIONS, 7.1. Special Populations, 7.1.4 Geriatrics 12/2022 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Addiction, Abuse and Misuse 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dosage and Dosage Adjustment 7 WARNINGS AND PRECAUTIONS, Withdrawal 12/2022 _ _ _Product Monograph _ _ _ _ATIVAN (lorazepam) _ _Page 3 of 32 _ 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 .............................................................................................................. 3 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 5 1 INDICATIONS .............................................................. সম্পূর্ণ নথি পড়ুন