PROVERA 100MG TABLETS

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

MEDROXYPROGESTERONE ACETATE

Disponible desde:

PFIZER CANADA ULC

Código ATC:

G03DA02

Designación común internacional (DCI):

MEDROXYPROGESTERONE

Dosis:

100MG

formulario farmacéutico:

TABLET

Composición:

MEDROXYPROGESTERONE ACETATE 100MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

PROGESTINS

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2012-02-13

Ficha técnica

_ _
_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