TAKHZYRO SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

LANADELUMAB

Tilgjengelig fra:

TAKEDA CANADA INC

ATC-kode:

B06AC05

INN (International Name):

LANADELUMAB

Dosering :

300MG

Legemiddelform:

SOLUTION

Sammensetning:

LANADELUMAB 300MG

Administreringsrute:

SUBCUTANEOUS

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

COMPLEMENT INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0160670001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-03-22

Preparatomtale

_TAKHZYRO_
_® _
_(lanadelumab injection) _
_ _
_Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TAKHZYRO
®
lanadelumab injection
Prefilled Syringes and Vials
300 mg/ 2mL Solution for Subcutaneous Injection
Monoclonal antibody inhibitor of plasma kallikrein
ATC code: B06AC05
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario
M5H 4E3
SUBMISSION CONTROL NO: 249492
DATE OF INITIAL APPROVAL: September 19, 2018
DATE OF REVISION: March 22, 2021
TAKHZYRO is a registered trademark of Dyax Corp.
TAKEDA
TM
is a trademark of Takeda Pharmaceutical Company Limited, used under
license.
_TAKHZYRO_
_®_
_ (lanadelumab injection) _
_ _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
Introduction of Prefilled Syringe Presentation.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
PRODUCT MONOGRAPH
.........................................................................................................
1
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
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.3
Administration
..................................................................