RIVA-ZOPICLONE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ZOPICLONE

Dostopno od:

LABORATOIRE RIVA INC.

Koda artikla:

N05CF01

INN (mednarodno ime):

ZOPICLONE

Odmerek:

7.5MG

Farmacevtska oblika:

TABLET

Sestava:

ZOPICLONE 7.5MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Povzetek izdelek:

Active ingredient group (AIG) number: 0122562001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2006-03-09

Lastnosti izdelka

_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