ADTRALZA SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

TRALOKINUMAB

متاح من:

LEO PHARMA INC

ATC رمز:

D11AH07

INN (الاسم الدولي):

TRALOKINUMAB

جرعة:

150MG

الشكل الصيدلاني:

SOLUTION

تركيب:

TRALOKINUMAB 150MG

طريقة التعاطي:

SUBCUTANEOUS

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2021-10-13

خصائص المنتج

_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