ESTRADOT 37.5 PATCH

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ESTRADIOL

Mevcut itibaren:

SANDOZ CANADA INCORPORATED

ATC kodu:

G03CA03

INN (International Adı):

ESTRADIOL

Doz:

37.5MCG

Farmasötik formu:

PATCH

Kompozisyon:

ESTRADIOL 37.5MCG

Uygulama yolu:

TRANSDERMAL

Paketteki üniteler:

8

Reçete türü:

Prescription

Terapötik alanı:

ESTROGENS

Ürün özeti:

Active ingredient group (AIG) number: 0106457034; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2022-12-06

Ürün özellikleri

_ _
_ESTRADOT® _
_Page 1 of 42_
PRODUCT MONOGRAPH
Pr
ESTRADOT
®
25
Transdermal Therapeutic System
25µg/24 hours of estradiol
Pr
ESTRADOT
®
37.5
37.5µg/24 hours of estradiol
Pr
ESTRADOT
®
50
50µg/24 hours of estradiol
Pr
ESTRADOT
®
75
75µg/24 hours of estradiol
Pr
ESTRADOT
®
100
100 µg/24 hours of estradiol
(Estradiol-17ß)
Estrogen
NOVARTIS PHARMACEUTICALS CANADA INC.
385 Bouchard Blvd.,
Dorval, Quebec H9S 1A9
Control # 201795
Date of Revision:
August 18, 2017
ESTRADOT is a registered trademark
_ _
_ESTRADOT® _
_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
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
STORAGE AND STABILITY
..........................................................................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
...............................................