PROVERA PAK 5MG TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-01-2014
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Active ingredient:
MEDROXYPROGESTERONE ACETATE
Available from:
PFIZER CANADA ULC
ATC code:
G03DA02
INN (International Name):
MEDROXYPROGESTERONE
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
MEDROXYPROGESTERONE ACETATE 5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PROGESTINS
Product summary:
Active ingredient group (AIG) number: 0106339005; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2014-03-26
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PROVERA*
(medroxyprogesterone acetate tablets USP)
2.5 mg, 5 mg and 10 mg tablets
and
PR
PROVERA-PAK*
(medroxyprogesterone acetate tablets USP)
5 mg and 10 mg tablets
PROGESTIN
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
December 23, 2013
SUBMISSION CONTROL NO: 168726
* TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2013
_ _
_PROVERA / PROVERA-PAK (medroxyprogesterone acetate) Product Monograph
_
_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
......................................................................
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