EMPAVELI SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

PEGCETACOPLAN

Dostupno od:

SWEDISH ORPHAN BIOVITRUM AB (PUBL)

ATC koda:

L04AJ03

INN (International ime):

PEGCETACOPLAN

Doziranje:

1080MG

Farmaceutski oblik:

SOLUTION

Sastav:

PEGCETACOPLAN 1080MG

Administracija rute:

SUBCUTANEOUS

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Proizvod sažetak:

Active ingredient group (AIG) number: 0164341001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2022-12-08

Svojstava lijeka

_EMPAVELI™ _
_(pegcetacoplan injection) _
_Product Monograph _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
EMPAVELI™
Pegcetacoplan injection
Solution, 1080 mg / 20 mL (54 mg/mL) for subcutaneous infusion use
Selective immunosuppressants
Swedish Orphan Biovitrum AB (publ)
SE-112 76, Stockholm,
Sweden
Imported by:
C.R.I.
3544 North Service Road, Unit #400
Burlington, Ontario
L7N 3G2
Date of Initial Authorization:
DEC. 07, 2022
Submission Control Number: 263432
EMPAVELI™ is a trademark of Swedish Orphan Biovitrum AB (publ).
Copyright 2022 Swedish
Orphan Biovitrum (publ). All rights reserved.
_EMPAVELI™ (pegcetacoplan injection) _
_Product Monograph _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment......................................