LETROZOLE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

LETROZOLE

제공처:

SIVEM PHARMACEUTICALS ULC

ATC 코드:

L02BG04

INN (국제 이름):

LETROZOLE

복용량:

2.5MG

약제 형태:

TABLET

구성:

LETROZOLE 2.5MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

제품 요약:

Active ingredient group (AIG) number: 0132937001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2022-01-13

제품 특성 요약

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LETROZOLE
letrozole tablets
Tablets, 2.5 mg, for oral use
USP
Aromatase inhibitor
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Submission Control No.:
279004
Date of Initial Authorization:
JAN
13, 2022
Date of Revision:
OCT 12, 2023
_LETROZOLE_ – _Product Monograph_
Page 2 of 59
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, MUSCULOSKELETAL
10/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1.
INDICATIONS
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4
1.1.
Paediatrics
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4
1.2.
Geriatrics
...........................................................................................................................
4
2.
CONTRAINDICATIONS
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5
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4.
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1.
Dosing Considerations
......................................................................................................
5
4.2.
Recommended Dose and Dosage Adjustment
................................................................. 5
4.4.
Administration
..................................................................................................................
6
4.5.
Missed Dose
......................................................................................................................
6
5.
OVERDOSAGE
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