ESTRACE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESTRADIOL

Available from:

PHARMASCIENCE INC

ATC code:

G03CA03

INN (International Name):

ESTRADIOL

Dosage:

0.5MG

Pharmaceutical form:

TABLET

Composition:

ESTRADIOL 0.5MG

Administration route:

ORAL

Units in package:

250ML

Prescription type:

Prescription

Therapeutic area:

ESTROGENS

Product summary:

Active ingredient group (AIG) number: 0106457006; AHFS:

Authorization status:

APPROVED

Authorization date:

2003-08-01

Summary of Product characteristics

_ _
_ESTRACE (17β-estradiol) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ESTRACE®
17β-estradiol Tablets
Tablets 0.5 mg, 1 mg, 2 mg
USP
Estrogen
Pharmascience Inc.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
Canada H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
OCT 25, 2022
Submission Control Number: 267802
_ _
_ _
_ESTRACE (17β-estradiol) _
_Page 2 of 32_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.5
Missed Dose
..............................................................................................................
6
5
OVERDOSAGE
.............................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
..................