Država: Kanada
Jezik: angleščina
Source: Health Canada
ZOPICLONE
LABORATOIRE RIVA INC.
N05CF01
ZOPICLONE
5MG
TABLET
ZOPICLONE 5MG
ORAL
100
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0122562002; AHFS:
APPROVED
2006-03-09
_RIVA-ZOPICLONE (zopiclone) _ _Page 1 of 40_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR RIVA-ZOPICLONE Zopiclone Tablets Tablets, 5 mg and 7.5 mg, Oral House Standard Hypnotic and Sedative LABORATOIRE RIVA INC. 660 Boul. Industriel Blainville, Quebec J7C 3V4 www.labriva.com Submission Control Number: 272444 Date of Initial Authorization: MAR 09, 2006 Date of Revision: MAR 10, 2023 _RIVA-ZOPICLONE (zopiclone) _ _Page 2 of 40_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.2 Geriatrics 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 7 WARNINGS AND PRECAUTIONS 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 (< 18 years of age) ................................................................................... 4 1.2 Geriatrics ( ≥ 65 years of age) .................................................................................. 4 2 CONTRAINDICATIONS .................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 6 4.1 Dosing Considerations ............................................................................................. 6 4.2 Recommended Dose and Dosage Adjustment ......................................................... 6 4.4 Adm Preberite celoten dokument