TEVA-MEDROXYPROGESTERONE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

MEDROXYPROGESTERONE ACETATE

Disponible desde:

TEVA CANADA LIMITED

Código ATC:

G03DA02

Designación común internacional (DCI):

MEDROXYPROGESTERONE

Dosis:

5MG

formulario farmacéutico:

TABLET

Composición:

MEDROXYPROGESTERONE ACETATE 5MG

Vía de administración:

ORAL

Unidades en paquete:

100/500/1000

tipo de receta:

Prescription

Área terapéutica:

PROGESTINS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2011-01-18

Ficha técnica

PRODUCT MONOGRAPH
PR
TEVA-MEDROXYPROGESTERONE
medroxyprogesterone acetate tablets USP
2.5 mg, 5 mg and 10 mg
PROGESTIN
Teva Canada Limited
Date of Revision:
30 Novopharm Court
May 12, 2014
Toronto, Ontario
M1B 2K9
Control No: 173232
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
..........................................................................................................
16
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
...............................................................................
25
PHARMACEUTICAL INFORMATION
.................................................................................
25
CLINICAL
TRIALS..................................................................................................................
26
DETAILED PHARMACOLOGY
.............................................................................................
28
TOXICOLOGY
..............