দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
ZOLPIDEM TARTRATE
MINT PHARMACEUTICALS INC
N05CF02
ZOLPIDEM
10MG
TABLET (ORALLY DISINTEGRATING)
ZOLPIDEM TARTRATE 10MG
SUBLINGUAL
15G/50G
Targeted (CDSA IV)
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0122857002; AHFS:
APPROVED
2019-09-13
_MINT-ZOLPIDEM ODT (Zolpidem Tartrate Sublingual Orally Disintegrating Tablets) _ _Page 1 of 51_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION T\C MINT-ZOLPIDEM ODT Zolpidem Tartrate Sublingual Orally Disintegrating Tablets (ODT) 5 mg and 10 mg, oral Manufacturer’s Standard Hypnotic Agent Mint Pharmaceuticals Inc. 6575 Davand Dr Mississauga, ON L5T 2M3 Date of Initial Authorization: SEP 25, 2019 Date of Revision: AUG 21, 2023 Submission Control Number: 274296 _MINT-ZOLPIDEM ODT (Zolpidem Tartrate Sublingual Orally Disintegrating Tablets) _ _Page 2 of 51_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.2 Geriatrics 08/2023 2 CONTRAINDICATIONS 08/2023 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 08/2023 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 08/2023 7 WARNINGS AND PRECAUTIONS 08/2023 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 08/2023 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 ...................................................................... সম্পূর্ণ নথি পড়ুন