Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
ESTRADIOL (ESTRADIOL HEMIHYDRATE)
BAYER INC
G03CA03
ESTRADIOL
100MCG
PATCH
ESTRADIOL (ESTRADIOL HEMIHYDRATE) 100MCG
TRANSDERMAL
4
Prescription
ESTROGENS
Active ingredient group (AIG) number: 0106457037; AHFS:
CANCELLED POST MARKET
2018-07-26
_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 ..................... Διαβάστε το πλήρες έγγραφο