PROVERA 5MG 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:

5MG

Bentuk farmasi:

TABLET

Komposisi:

MEDROXYPROGESTERONE ACETATE 5MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

PROGESTINS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

1998-03-05

Karakteristik produk

_ _
_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
...........................................................................................