PROVERA 100MG TABLETS

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

MEDROXYPROGESTERONE ACETATE

Boleh didapati daripada:

PFIZER CANADA ULC

Kod ATC:

G03DA02

INN (Nama Antarabangsa):

MEDROXYPROGESTERONE

Dos:

100MG

Borang farmaseutikal:

TABLET

Komposisi:

MEDROXYPROGESTERONE ACETATE 100MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

PROGESTINS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2012-02-13

Ciri produk

_ _
_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