ADTRALZA SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TRALOKINUMAB

Disponível em:

LEO PHARMA INC

Código ATC:

D11AH07

DCI (Denominação Comum Internacional):

TRALOKINUMAB

Dosagem:

150MG

Forma farmacêutica:

SOLUTION

Composição:

TRALOKINUMAB 150MG

Via de administração:

SUBCUTANEOUS

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Área terapêutica:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0163195001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2021-10-13

Características técnicas

_Product Monograph _
_ _
_Pr_
_ADTRALZA_
_®_
_ (tralokinumab injection) _
_Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ADTRALZA
®
Tralokinumab injection
Single-use pre-filled syringe (150 mg/1 mL)
Single-use pre-filled pen (300 mg/2 mL)
Solution for subcutaneous injection
Immunomodulator, Interleukin inhibitor
ATC Code: D11AH07
LEO Pharma Inc.
Toronto, Ontario
M2H 3S8
www.leo-pharma.ca
Date of Initial Authorization:
October 13, 2021
Date of Revision:
August 4, 2023
Submission Control Number: 270639
®
Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc. Canada
_ _
_Product Monograph _
_ _
_Pr_
_ADTRALZA_
_®_
_ (tralokinumab injection) _
_Page 2 of 48_
RECENT MAJOR LABEL CHANGES
1 Indications
02/2023
1 Indications, 1.1 Pediatrics
02/2023
4 Dosage and Administration, 4.1 Dosing Considerations
02/2023
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
07/2023
4 Dosage and Administration, 4.4 Administration
07/2023
7 Warnings and Precautions, 7.1.3 Pediatrics
02/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
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
4
DOSAGE AND ADMINISTRATION