OESCLIM PATCH

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESTRADIOL

Available from:

SEARCHLIGHT PHARMA INC

ATC code:

G03CA03

INN (International Name):

ESTRADIOL

Dosage:

75MCG

Pharmaceutical form:

PATCH

Composition:

ESTRADIOL 75MCG

Administration route:

TRANSDERMAL

Units in package:

8

Prescription type:

Prescription

Therapeutic area:

ESTROGENS

Product summary:

Active ingredient group (AIG) number: 0106457036; AHFS:

Authorization status:

APPROVED

Authorization date:

2001-04-04

Summary of Product characteristics

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_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
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_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
..........................................................