ESTRADERM-100 PATCH (EXTENDED RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ESTRADIOL

Disponible depuis:

NOVARTIS PHARMACEUTICALS CANADA INC

Code ATC:

G03CA03

DCI (Dénomination commune internationale):

ESTRADIOL

Dosage:

8MG

forme pharmaceutique:

PATCH (EXTENDED RELEASE)

Composition:

ESTRADIOL 8MG

Mode d'administration:

TRANSDERMAL

Unités en paquet:

8 PATCHES

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ESTROGENS

Descriptif du produit:

Active ingredient group (AIG) number: 0106457012; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2013-01-08

Résumé des caractéristiques du produit

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_ESTRADERM* _
_Page 1 of 42_
PRODUCT MONOGRAPH
PR
ESTRADERM*25
ESTRADERM*100
(Estradiol-17ß)
Transdermal Therapeutic System
25, and 100 µg/24 hours of estradiol
Estrogen
* ESTRADERM is a registered trademark
NOVARTIS PHARMACEUTICALS CANADA INC.
Dorval, Québec,
H9S 1A9
Control # 147762
Date of Revision:
August 24, 2011
_ _
_ _
_ESTRADERM* _
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS..................................................................................................12
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND
ADMINISTRATION..............................................................................18
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL
INFORMATION..........................................................................26
CLINICAL
TRIALS..........................................................................................................26
DETAILED
PHARMACOLOGY.....................................................................................29
REFERENCES
..................................................................................................................30
PAR