ESTRADOT 100 PATCH

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ESTRADIOL

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

G03CA03

INN (Kansainvälinen yleisnimi):

ESTRADIOL

Annos:

100MCG

Lääkemuoto:

PATCH

Koostumus:

ESTRADIOL 100MCG

Antoreitti:

TRANSDERMAL

Kpl paketissa:

8

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ESTROGENS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0106457037; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2022-12-06

Valmisteyhteenveto

_ _
_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
SANDOZ CANADA INC.
110 Rue de Lauzon
Boucherville, Quebec
Canada J4B 1E6
Control # 269091
ESTRADOT is a registered trademark
Date of
Initial Approval:
DEC 6, 2022
_ _
_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
....................................................