AMVUTTRA SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

VUTRISIRAN (VUTRISIRAN SODIUM)

Pieejams no:

ALNYLAM NETHERLANDS B.V.

ATĶ kods:

N07XX18

SNN (starptautisko nepatentēto nosaukumu):

VUTRISIRAN

Deva:

25MG

Zāļu forma:

SOLUTION

Kompozīcija:

VUTRISIRAN (VUTRISIRAN SODIUM) 25MG

Ievadīšanas:

SUBCUTANEOUS

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2023-10-18

Produkta apraksts

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