Maa: Kanada
Kieli: englanti
Lähde: Health Canada
LORAZEPAM
AA PHARMA INC
N05BA06
LORAZEPAM
2MG
TABLET
LORAZEPAM 2MG
SUBLINGUAL
100/500
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0110731002; AHFS:
APPROVED
2013-08-14
_Lorazepam Sublingual (lorazepam) _ _ _ _Page 1 of 33 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION LORAZEPAM SUBLINGUAL Lorazepam Sublingual Tablets Tablets, 0.5 mg, 1 mg and 2 mg, Sublingual Anxiolytic - Sedative Submission Control Number: 274298 AA PHARMA INC. 1165 Credistone Road, Unit #1 Vaughan, Ontario L4K 4N7 Date of Initial Authorization: OCT 16, 2013 Date of Revision: JUN 21, 2023 _Lorazepam Sublingual (lorazepam) _ _ _ _Page 2 of 33 _ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.2 Geriatrics 06/2023 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 06/2023 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 06/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 06/2023 7 WARNINGS AND PRECAUTIONS 06/2023 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 06/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ..................................................................................... 1 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 .................................................................................. 5 4.1 Dosing Considerations ............................. Lue koko asiakirja