AMVUTTRA SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

VUTRISIRAN (VUTRISIRAN SODIUM)

제공처:

ALNYLAM NETHERLANDS B.V.

ATC 코드:

N07XX18

INN (국제 이름):

VUTRISIRAN

복용량:

25MG

약제 형태:

SOLUTION

구성:

VUTRISIRAN (VUTRISIRAN SODIUM) 25MG

관리 경로:

SUBCUTANEOUS

패키지 단위:

15G/50G

처방전 유형:

Prescription

제품 요약:

Active ingredient group (AIG) number: 0165141001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2023-10-18

제품 특성 요약

_Product Monograph _
_AMVUTTRA (vutrisiran injection) _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AMVUTTRA
®
vutrisiran injection
solution; 25 mg/0.5 mL vutrisiran (as vutrisiran sodium); subcutaneous
injection
ATC Code N07XX18
other nervous system drugs
Alnylam Netherlands B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
Netherlands
Imported / Distributed by:
Innomar-Strategies
Oakville, ON
L6L 0C4
Date of Initial Authorization:
October 17, 2023
Submission Control Number: 267923
_ _
_Product Monograph _
_AMVUTTRA (vutrisiran injection) _
_Page 2 of 26_
RECENT MAJOR LABEL CHANGES
There are no recent major changes to this Product Monograph.
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
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
........................................................................................................
5
4.5
Missed Dose
.........................