PROVERA 100MG TABLETS

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Osta se nyt

Valmisteyhteenveto Valmisteyhteenveto (SPC)
22-12-2009

Aktiivinen ainesosa:

MEDROXYPROGESTERONE ACETATE

Saatavilla:

PFIZER CANADA ULC

ATC-koodi:

G03DA02

INN (Kansainvälinen yleisnimi):

MEDROXYPROGESTERONE

Annos:

100MG

Lääkemuoto:

TABLET

Koostumus:

MEDROXYPROGESTERONE ACETATE 100MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

PROGESTINS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0106339007; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2012-02-13

Valmisteyhteenveto

                                _ _
_PROVERA / PROVERA-PAK (medroxyprogesterone acetate) Product Monograph
_
_Page 1 of 42_
PRODUCT MONOGRAPH
PR
PROVERA*
(medroxyprogesterone acetate USP)
2.5 mg, 5 mg, 10 mg and 100 mg tablets
and
PR
PROVERA-PAK*
(medroxyprogesterone acetate USP)
5 mg and 10 mg tablets
PROGESTIN
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
DATE OF REVISION:
December 9, 2009
SUBMISSION CONTROL NO: 133050
* TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2009
_PROVERA / PROVERA-PAK (medroxyprogesterone acetate) Product Monograph
_
_Page 2 of 42_
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
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND
STABILITY..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL
INFORMATION..........................................................................27
CLINICAL
TRIAL
                                
                                Lue koko asiakirja
                                
                            

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