ONPATTRO SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PATISIRAN (PATISIRAN SODIUM)

Mevcut itibaren:

ALNYLAM NETHERLANDS B.V.

ATC kodu:

N07XX12

INN (International Adı):

PATISIRAN

Doz:

2MG

Farmasötik formu:

SOLUTION

Kompozisyon:

PATISIRAN (PATISIRAN SODIUM) 2MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0161490001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2019-06-07

Ürün özellikleri

_ _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ONPATTRO®
patisiran lipid complex for injection
lipid complex solution; 2 mg/mL patisiran (as patisiran sodium);
intravenous
ATC Code N07XX12
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 Approval:
June 07, 2019
Date of Revision:
June 12, 2023
Submission Control No: 266240
_ _
_ONPATTRO (patisiran) Product Monograph _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
4.3
Reconstitution
.....................................................................................................6
4.4
Administration
................................................................