PREMARIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CONJUGATED ESTROGENS

Disponible desde:

PFIZER CANADA ULC

Código ATC:

G03CA57

Designación común internacional (DCI):

CONJUGATED ESTROGENS

Dosis:

0.625MG

formulario farmacéutico:

TABLET

Composición:

CONJUGATED ESTROGENS 0.625MG

Vía de administración:

ORAL

Unidades en paquete:

30/100/1000

tipo de receta:

Prescription

Área terapéutica:

ESTROGENS

Resumen del producto:

Active ingredient group (AIG) number: 0106442006; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2017-08-02

Ficha técnica

_Premarin_

_ (conjugated_
_ _
_estrogens tablets, CSD) _
_Page 1 of 42_
COMPLETE PRESCRIBING INFORMATION
Pr
PREMARIN
®
(conjugated estrogens tablets, CSD)
0.3 mg, 0.625 mg, and 1.25 mg
ESTROGENIC HORMONES
® Wyeth Canada
Pfizer Canada Inc., Licensee
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
January 10, 2012
Submission Control No: 148504
_Premarin_

_ (conjugated_
_ _
_estrogens tablets, CSD) _
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION...........................................................................3
INDICATIONS AND CLINICAL USE
................................................................................3
CONTRAINDICATIONS......................................................................................................4
WARNINGS AND PRECAUTIONS
....................................................................................4
ADVERSE REACTIONS
....................................................................................................14
DRUG INTERACTIONS
....................................................................................................19
DOSAGE AND ADMINISTRATION
................................................................................22
OVERDOSAGE...................................................................................................................25
ACTION AND CLINICAL
PHARMACOLOGY...............................................................25
STORAGE AND STABILITY
............................................................................................28
SPECIAL HANDLING
INSTRUCTIONS..........................................................................28
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
....