HEMLIBRA SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

EMICIZUMAB

Saadav alates:

HOFFMANN-LA ROCHE LIMITED

ATC kood:

B02BX06

INN (Rahvusvaheline Nimetus):

EMICIZUMAB

Annus:

150MG

Ravimvorm:

SOLUTION

Koostis:

EMICIZUMAB 150MG

Manustamisviis:

SUBCUTANEOUS

Ühikuid pakis:

15G/50G

Retsepti tüüp:

Prescription

Terapeutiline ala:

ANTIHEMORRHAGIC AGENTS, MISCELLANEOUS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0160531002; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2018-08-02

Toote omadused

_Product Monograph Master Template _
_September 2020 _
_HEMLIBRA_
_®_
_ (emicizumab injection) _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
HEMLIBRA
®
emicizumab injection
Solution
30 mg/mL, 60 mg/0.4 mL (150 mg/mL), 105 mg/0.7 mL (150 mg/mL), 150
mg/mL
Subcutaneous
Professed
Antihemorrhagic
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, ON L5N 5M8
Date of Initial Approval:
August 2, 2018
Date of Revision:
December 23, 2022
Submission Control Number: 261138
_ _
_Product Monograph Master Template _
_September 2020 _
_HEMLIBRA_
_®_
_ (emicizumab injection) Page 2 of 64 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
12/2022
7 WARNINGS AND PRECAUTIONS
11/2021
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.3
Reconstitution
...