ESTRADERM-50 PATCH (EXTENDED RELEASE)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ESTRADIOL

Pieejams no:

NOVARTIS PHARMACEUTICALS CANADA INC

ATĶ kods:

G03CA03

SNN (starptautisko nepatentēto nosaukumu):

ESTRADIOL

Deva:

4MG

Zāļu forma:

PATCH (EXTENDED RELEASE)

Kompozīcija:

ESTRADIOL 4MG

Ievadīšanas:

TRANSDERMAL

Vienības iepakojumā:

8 PATCHES

Receptes veids:

Prescription

Ārstniecības joma:

ESTROGENS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2010-05-10

Produkta apraksts

_ _
_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
_ _
_ _
_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
.....................................................................................