MERIDIA CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE

זמין מ:

ABBOTT LABORATORIES, LIMITED

קוד ATC:

A08AA10

INN (שם בינלאומי):

SIBUTRAMINE

כמות:

15MG

טופס פרצבטיות:

CAPSULE

הרכב:

SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE 15MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30

סוג מרשם:

Prescription

איזור תרפויטי:

ANOREXIGENIC AGENTS & RESPIRATORY AND CEREBRAL STIMULANTS, MISCELLANEOUS

leaflet_short:

Active ingredient group (AIG) number: 0142562002; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2010-10-12

מאפייני מוצר

_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