Kraj: Kanada
Język: angielski
Źródło: Health Canada
ZOPICLONE
COBALT PHARMACEUTICALS COMPANY
N05CF01
ZOPICLONE
5MG
TABLET
ZOPICLONE 5MG
ORAL
100/500
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0122562002; AHFS:
CANCELLED PRE MARKET
2017-09-01
_ _ _ _ ZOPICLONE _ _ _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 _ _ _ _ ZOPICLONE _ _ _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....................................................................... Przeczytaj cały dokument