GIVLAARI SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

GIVOSIRAN (GIVOSIRAN SODIUM)

Pieejams no:

ALNYLAM NETHERLANDS B.V.

ATĶ kods:

A16AX16

SNN (starptautisko nepatentēto nosaukumu):

GIVOSIRAN

Deva:

189MG

Zāļu forma:

SOLUTION

Kompozīcija:

GIVOSIRAN (GIVOSIRAN SODIUM) 189MG

Ievadīšanas:

SUBCUTANEOUS

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0162538001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2020-10-09

Produkta apraksts

_GIVLAARI (givosiran) _
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_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
GIVLAARI®
Givosiran Injection
Solution, 189 mg/mL givosiran (as givosiran sodium), subcutaneous
injection
Various alimentary tract and metabolism products
Alnylam Netherlands B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
Netherlands
Imported / Distributed by:
Innomar Strategies Inc.
Oakville, ON
L6L 0C4
Date of Initial Authorization:
OCT 08, 2020
Date of Revision:
SEPT 18, 2023
Submission Control Number: 275066
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_GIVLAARI (givosiran) _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
Not applicable. TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..........................................................................................
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
.............................................................................................................
6
5
OVERDOSAGE
.................................................................