ESTRADERM-50 PATCH (EXTENDED RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ESTRADIOL

Disponibil de la:

NOVARTIS PHARMACEUTICALS CANADA INC

Codul ATC:

G03CA03

INN (nume internaţional):

ESTRADIOL

Dozare:

4MG

Forma farmaceutică:

PATCH (EXTENDED RELEASE)

Compoziție:

ESTRADIOL 4MG

Calea de administrare:

TRANSDERMAL

Unități în pachet:

8 PATCHES

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ESTROGENS

Rezumat produs:

Active ingredient group (AIG) number: 0106457011; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2010-05-10

Caracteristicilor produsului

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_ESTRADERM* _
_Page 1 of 41_
PRODUCT MONOGRAPH
PR
ESTRADERM*25
ESTRADERM*50
ESTRADERM*100
(Estradiol-17ß)
Transdermal Therapeutic System
25, 50, and 100 µg/24 hours of estradiol
Estrogen
* ESTRADERM is a registered trademark
NOVARTIS PHARMACEUTICALS CANADA INC.
Dorval, Québec,
H9S 1A9
Submission Control Number: 120571
Date of Revision:
January 23, 2009
_ _
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_ESTRADERM* _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS..................................................................................................11
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL
INFORMATION..........................................................................25
CLINICAL
TRIALS..........................................................................................................25
DETAILED
PHARMACOLOGY.....................................................................................28
REFERENCES
.....................................................................................