AMVUTTRA SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

VUTRISIRAN (VUTRISIRAN SODIUM)

Dostupno od:

ALNYLAM NETHERLANDS B.V.

ATC koda:

N07XX18

INN (International ime):

VUTRISIRAN

Doziranje:

25MG

Farmaceutski oblik:

SOLUTION

Sastav:

VUTRISIRAN (VUTRISIRAN SODIUM) 25MG

Administracija rute:

SUBCUTANEOUS

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2023-10-18

Svojstava lijeka

_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
.........................