MEGACE OS SUSPENSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-10-2016
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Active ingredient:
MEGESTROL ACETATE
Available from:
BRISTOL-MYERS SQUIBB CANADA
ATC code:
L02AB01
INN (International Name):
MEGESTROL
Dosage:
40MG
Pharmaceutical form:
SUSPENSION
Composition:
MEGESTROL ACETATE 40MG
Administration route:
ORAL
Units in package:
240ML
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0111633001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-10-20
Summary of Product characteristics
_ _
MEGACE OS (megestrol acetate)_ _
_Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MEGACE
® OS
(MEGESTROL ACETATE)
ORAL SUSPENSION USP, 40 MG/ML
ANTIANOREXIC / ANTICACHECTIC
Bristol-Myers Squibb Canada
Montreal, Canada
H4S 0A4
Date of Revision:
October 06, 2016
®
Registered trademark of E.R. Squibb & Sons, L.L.C.
used under licence by Bristol-Myers Squibb Canada.
Submission Control No: 195954
_ _
MEGACE OS (megestrol acetate)_ _
_Page 2 of 21_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
...............................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................
3
ADVERSE REACTIONS
................................................................................................
5
DRUG INTERACTIONS
................................................................................................
6
DOSAGE AND ADMINISTRATION
.............................................................................
7
OVERDOSAGE
..............................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 7
STORAGE AND STABILITY
........................................................................................
9
SPECIAL HANDLING INSTRUCTIONS
......................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 9
PART II: SCIENTIFIC INFORMATION
............................................................................
10
PHARMACEUTICAL
INFORMATION.....................
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