POTELIGEO SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

MOGAMULIZUMAB

متاح من:

KYOWA KIRIN, INC.

ATC رمز:

L01FX09

INN (الاسم الدولي):

MOGAMULIZUMAB

جرعة:

4MG

الشكل الصيدلاني:

SOLUTION

تركيب:

MOGAMULIZUMAB 4MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Schedule D

ملخص المنتج:

Active ingredient group (AIG) number: 0163781001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2022-06-02

خصائص المنتج

_POTELIGEO (mogamulizumab for injection) _
_Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
POTELIGEO
®
Mogamulizumab for injection
20 mg/5 mL single-use vial
Intravenous Infusion, 4 mg/mL
Antineoplastic
ATC Code: L01FX09
Kyowa Kirin, Inc.
135 Route 202/206, Suite 6
Bedminster, NJ 07921 USA
www.kyowakirin.ca
DISTRIBUTOR:
Innomar Strategies
3470 Superior Court
Oakville, ON
L6L 0C4
http://www.innomar-strategies.com
Date of Initial Authorization:
June 2, 2022
Date of Revision:
June 20, 2022
Submission Control Number: 251277
_ _
_POTELIGEO (mogamulizumab for injection) _
_Page 2 of 25_
RECENT MAJOR LABEL CHANGES
N/A
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...................................................................................4
4.1
Dosing Considerations
.........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.......................................................4
4.3
Reconstitution
...........................................................................