CLIMARA 100 PATCH
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-03-2016
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Active ingredient:
ESTRADIOL (ESTRADIOL HEMIHYDRATE)
Available from:
BAYER INC
ATC code:
G03CA03
INN (International Name):
ESTRADIOL
Dosage:
100MCG
Pharmaceutical form:
PATCH
Composition:
ESTRADIOL (ESTRADIOL HEMIHYDRATE) 100MCG
Administration route:
TRANSDERMAL
Units in package:
4
Prescription type:
Prescription
Therapeutic area:
ESTROGENS
Product summary:
Active ingredient group (AIG) number: 0106457037; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-07-26
Summary of Product characteristics
_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
.....................
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