CLIMARA 100 PATCH
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
08-03-2016
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ESTRADIOL (ESTRADIOL HEMIHYDRATE)
Fáanlegur frá:
BAYER INC
ATC númer:
G03CA03
INN (Alþjóðlegt nafn):
ESTRADIOL
Skammtar:
100MCG
Lyfjaform:
PATCH
Samsetning:
ESTRADIOL (ESTRADIOL HEMIHYDRATE) 100MCG
Stjórnsýsluleið:
TRANSDERMAL
Einingar í pakka:
4
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ESTROGENS
Vörulýsing:
Active ingredient group (AIG) number: 0106457037; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2018-07-26
Vara einkenni
_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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