OESCLIM PATCH

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ESTRADIOL

Tersedia dari:

SEARCHLIGHT PHARMA INC

Kode ATC:

G03CA03

INN (Nama Internasional):

ESTRADIOL

Dosis:

100MCG

Bentuk farmasi:

PATCH

Komposisi:

ESTRADIOL 100MCG

Rute administrasi :

TRANSDERMAL

Unit dalam paket:

8

Jenis Resep:

Prescription

Area terapi:

ESTROGENS

Ringkasan produk:

Active ingredient group (AIG) number: 0106457037; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2001-04-04

Karakteristik produk

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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
..........................................................