Страна: Канада
мова: англійська
Джерело: Health Canada
ESTRADIOL
NOVARTIS PHARMACEUTICALS CANADA INC
G03CA03
ESTRADIOL
4MG
PATCH (EXTENDED RELEASE)
ESTRADIOL 4MG
TRANSDERMAL
8 PATCHES
Prescription
ESTROGENS
Active ingredient group (AIG) number: 0106457011; AHFS:
CANCELLED POST MARKET
2010-05-10
_ _ _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 ..................................................................................... Прочитайте повний документ