ACH-LETROZOLE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

LETROZOLE

から入手可能:

ACCORD HEALTHCARE INC

ATCコード:

L02BG04

INN（国際名）:

LETROZOLE

投薬量:

2.5MG

医薬品形態:

TABLET

構図:

LETROZOLE 2.5MG

投与経路:

ORAL

パッケージ内のユニット:

30

処方タイプ:

Prescription

治療領域:

ANTINEOPLASTIC AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2014-05-02

製品の特徴

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACH-LETROZOLE
letrozole tablets
Tablets, 2.5 mg, for oral use
USP
Aromatase inhibitor
Accord Healthcare Inc.
3535 Boulevard St-Charles, Suite 704
Kirkland, Quebec H9H 5B9
Canada
Date of Initial Authorization:
April 28, 2010
Date of Revision:
June 2, 2023
Submission Control Number: 271070
ACH-Letrozole _(letrozole)_ Tablets
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, MUSCULOSKELETAL
05/2023
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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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
........................................................ 5
4.4.
Administration
..................................................................................................
6
4.5.
Missed Dose
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6
5.
OVERDOSAGE
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6
6.
DOSAGE