PROVERA 5MG TABLETS

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

MEDROXYPROGESTERONE ACETATE

Saatavilla:

PFIZER CANADA ULC

ATC-koodi:

G03DA02

INN (Kansainvälinen yleisnimi):

MEDROXYPROGESTERONE

Annos:

5MG

Lääkemuoto:

TABLET

Koostumus:

MEDROXYPROGESTERONE ACETATE 5MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

PROGESTINS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0106339005; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

1998-03-05

Valmisteyhteenveto

_ _
_PROVERA (medroxyprogesterone acetate) Product Monograph _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
PROVERA*
(medroxyprogesterone acetate tablets USP)
2.5 mg, 5 mg and 10 mg tablets
PROGESTIN
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
29 September 2014
SUBMISSION CONTROL NO: 176877
* TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2014
_ _
_PROVERA (medroxyprogesterone acetate) Product Monograph _
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
...........................................................................................