PROVERA PAK 10MG TABLETS

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MEDROXYPROGESTERONE ACETATE

Tersedia dari:

PFIZER CANADA ULC

Kode ATC:

G03DA02

INN (Nama Internasional):

MEDROXYPROGESTERONE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

MEDROXYPROGESTERONE ACETATE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

10

Jenis Resep:

Prescription

Area terapi:

PROGESTINS

Ringkasan produk:

Active ingredient group (AIG) number: 0106339006; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2014-04-04

Karakteristik produk

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
......................................................................