CLIMARA 100 PATCH

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ESTRADIOL (ESTRADIOL HEMIHYDRATE)

Tersedia dari:

BAYER INC

Kode ATC:

G03CA03

INN (Nama Internasional):

ESTRADIOL

Dosis:

100MCG

Bentuk farmasi:

PATCH

Komposisi:

ESTRADIOL (ESTRADIOL HEMIHYDRATE) 100MCG

Rute administrasi :

TRANSDERMAL

Unit dalam paket:

4

Jenis Resep:

Prescription

Area terapi:

ESTROGENS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-07-26

Karakteristik produk

_Page 1 of 49 _
PRODUCT MONOGRAPH
PR
CLIMARA
® 25
PR
CLIMARA
® 50
PR
CLIMARA
® 75
PR
CLIMARA
® 100
estradiol hemihydrate transdermal system
(estradiol-17β)
0.025 mg/day
0.05 mg/day
0.075 mg/day
0.1 mg/day
Estrogen
Bayer Inc.
2920 Matheson Boulevard East Mississauga,
Ontario
L4W 5R6
http://www.bayer.ca
Submission Control No.: 189319
© 2016, Bayer Inc.
Date of Revision:
February 17, 2016
® TM see www.bayer.ca/tm-mc
_Page 2 of 49 _
TABLE OF CONTENTS
PART
I:
HEALTH
PROFESSIONAL
INFORMATION ..........................................................
3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS
...........................................................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
12
DRUG INTERACTIONS
..........................................................................................................
16
DOSAGE AND ADMINISTRATION
......................................................................................
18
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
19
STORAGE AND STABILITY
.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 21
PART
II:
SCIENTIFIC
INFORMATION
................................................................................
22
PHARMACEUTICAL INFORMATION
.....................