MERIDIA CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-11-2009
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Active ingredient:
SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE
Available from:
ABBOTT LABORATORIES, LIMITED
ATC code:
A08AA10
INN (International Name):
SIBUTRAMINE
Dosage:
15MG
Pharmaceutical form:
CAPSULE
Composition:
SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE 15MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
ANOREXIGENIC AGENTS & RESPIRATORY AND CEREBRAL STIMULANTS, MISCELLANEOUS
Product summary:
Active ingredient group (AIG) number: 0142562002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2010-10-12
Summary of Product characteristics
_MERIDIA_
_®_
_ Product Monograph _
_Page 1 of 46 _
_ _
PRODUCT MONOGRAPH
PR
MERIDIA
®
sibutramine hydrochloride monohydrate
10 mg and 15 mg capsules
Anorexiant / Antiobesity Agent
Abbott Laboratories, Limited
Date of Revision:
8401 Trans-Canada Highway
November 26, 2009
St-Laurent, Qc H4S 1Z1
Submission Control No: 130400
_MERIDIA_
_®_
_ Product Monograph _
_Page 2 of 46 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................6
WARNINGS AND
PRECAUTIONS..................................................................................7
ADVERSE
REACTIONS..................................................................................................11
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND
ADMINISTRATION..............................................................................20
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND
STABILITY..........................................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
................................................................................27
PHARMACEUTICAL
INFORMATION..........................................................................27
CLINICAL
TRIALS..........................................................................................................27
D
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