ZOPICLONE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ZOPICLONE

Dostępny od:

COBALT PHARMACEUTICALS COMPANY

Kod ATC:

N05CF01

INN (International Nazwa):

ZOPICLONE

Dawkowanie:

7.5MG

Forma farmaceutyczna:

TABLET

Skład:

ZOPICLONE 7.5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2017-09-01

Charakterystyka produktu

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ZOPICLONE
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_Page 1 of 37_
PRODUCT MONOGRAPH
Pr
_ _ZOPICLONE
Zopiclone
Tablets, 5.0 mg and 7.5 mg
Hypnotic and Sedative
Manufactured by:
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Control Number: 136563
Date of Preparation:
February 16, 2010
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ZOPICLONE
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_Page 2 of 37_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND
PRECAUTIONS.................................................................................
5
ADVERSE
REACTIONS.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND
ADMINISTRATION.............................................................................
14
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 15
STORAGE AND
STABILITY.........................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
......................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 18
PART II: SCIENTIFIC INFORMATION
..............................................................................
20
PHARMACEUTICAL
INFORMATION.........................................................................
20
CLINICAL
TRIALS.......................................................................