ESTRADERM-50 PATCH (EXTENDED RELEASE)

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

ESTRADIOL

から入手可能:

NOVARTIS PHARMACEUTICALS CANADA INC

ATCコード:

G03CA03

INN（国際名）:

ESTRADIOL

投薬量:

4MG

医薬品形態:

PATCH (EXTENDED RELEASE)

構図:

ESTRADIOL 4MG

投与経路:

TRANSDERMAL

パッケージ内のユニット:

8 PATCHES

処方タイプ:

Prescription

治療領域:

ESTROGENS

製品概要:

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

認証ステータス:

CANCELLED POST MARKET

承認日:

2010-05-10

製品の特徴

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