REPATHA SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

EVOLOCUMAB

から入手可能:

AMGEN CANADA INC

ATCコード:

C10AX13

INN（国際名）:

EVOLOCUMAB

投薬量:

120MG

医薬品形態:

SOLUTION

構図:

EVOLOCUMAB 120MG

投与経路:

SUBCUTANEOUS

パッケージ内のユニット:

3.5ML

処方タイプ:

Prescription

治療領域:

PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9 (PCSK9) INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0157370002; AHFS:

認証ステータス:

APPROVED

承認日:

2016-12-15

製品の特徴

_REPATHA (evolocumab injection) _
_Page 1 of 82 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
REPATHA
®
evolocumab injection
Solution for Subcutaneous Injection
140 mg in 1.0 mL (140 mg/mL)
420 mg in 3.5 mL (120 mg/mL)
anti-Proprotein Convertase Subtilisin/Kexin Type 9 (anti-PCSK9)
Monoclonal Antibody produced
in Chinese hamster ovary (CHO) cells by recombinant DNA technology
Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, ON L5N 0A4
Date of Initial Authorization:
September 10, 2015
Date of Revision:
September 27, 2023
Submission Control Number: 269049
© 2015-2023 Amgen Canada Inc. All Rights Reserved.
_ _
_REPATHA (evolocumab injection) _
_Page 2 of 82_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
12/2021
1 INDICATIONS, 1.1 Pediatrics
12/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
12/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dose
Adjustment
12/2021
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
12/2021
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
.............................................................