Land: Canada
Taal: Engels
Bron: Health Canada
ESTRADIOL
SEARCHLIGHT PHARMA INC
G03CA03
ESTRADIOL
75MCG
PATCH
ESTRADIOL 75MCG
TRANSDERMAL
8
Prescription
ESTROGENS
Active ingredient group (AIG) number: 0106457036; AHFS:
APPROVED
2001-04-04
_ _ _Page 1 of 42_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR OESCLIM ® Estradiol-17β transdermal system 25 mcg / 24 hrs 37.5 mcg / 24 hrs 50 mcg / 24 hrs 75 mcg / 24 hrs 100 mcg / 24 hrs Estrogen Searchlight Pharma Inc. 1600 Notre Dame St. West, Suite 312 Montréal, Québec H3J 1M1 Date of Preparation: April 28, 2015 Date of Revision: February 23, 2017 Submission Control No: 199389 _ _ _ _ _Page 2 of 42_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................12 DRUG INTERACTIONS ..................................................................................................14 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................17 STORAGE AND STABILITY ..........................................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19 PART II: SCIENTIFIC INFORMATION ...............................................................................21 PHARMACEUTICAL INFORMATION ..........................................................................21 CLINICAL TRIALS .......................................................... Lees het volledige document