ESTROGEL

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ESTRADIOL (ESTRADIOL HEMIHYDRATE)

제공처:

ORGANON CANADA INC.

ATC 코드:

G03CA03

INN (국제 이름):

ESTRADIOL

복용량:

0.06%

약제 형태:

GEL

구성:

ESTRADIOL (ESTRADIOL HEMIHYDRATE) 0.06%

관리 경로:

TRANSDERMAL

패키지 단위:

80G

처방전 유형:

Prescription

치료 영역:

ESTROGENS

제품 요약:

Active ingredient group (AIG) number: 0106457004; AHFS:

승인 상태:

APPROVED

승인 날짜:

1998-09-15

제품 특성 요약

_ESTROGEL (17β-estradiol, as estradiol hemihydrate) _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ESTROGEL
®
17β-estradiol, as estradiol hemihydrate
Transdermal gel, 0.06% w/w
Estrogen
Organon Canada Inc.
16766 Trans-Canada highway
Kirkland QC H9H 4M7
Date of Initial Approval:
September 15, 1998
Date of Revision:
MAR 06, 2024
Submission Control No: 280464
_ _
_ESTROGEL (17β-estradiol, as estradiol hemihydrate) _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.1 Dosing considerations
08/2023
7 Warnings and Precautions
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
........................................................................................2
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
.......................................................4
4
DOSAGE AND ADMINISTRATION
.................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage Adjustment
....................................................6
4.4
Administration
.................................................