ESTRADIOL TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ESTRADIOL

Dostupné s:

PHARMASCIENCE INC

ATC kód:

G03CA03

INN (Mezinárodní Name):

ESTRADIOL

Dávkování:

0.5MG

Léková forma:

TABLET

Složení:

ESTRADIOL 0.5MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

ESTROGENS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2022-10-26

Charakteristika produktu

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_ESTRADIOL (17β-estradiol) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ESTRADIOL
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: 267798
_ _
_ _
_ESTRADIOL (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
..............