VYALEV SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

FOSLEVODOPA; FOSCARBIDOPA

זמין מ:

ABBVIE CORPORATION

קוד ATC:

N04BA07

INN (שם בינלאומי):

FOSLEVODOPA AND DECARBOXYLASE INHIBITOR

כמות:

240MG; 12MG

טופס פרצבטיות:

SOLUTION

הרכב:

FOSLEVODOPA 240MG; FOSCARBIDOPA 12MG

מסלול נתינה (של תרופות):

SUBCUTANEOUS

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

leaflet_short:

Active ingredient group (AIG) number: 0264641001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2023-05-03

מאפייני מוצר

_VYALEV (foslevodopa/foscarbidopa) _
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_Page 1 of 53_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VYALEV™
foslevodopa/foscarbidopa solution
Solution, 240 mg/mL foslevodopa and 12 mg/mL foscarbidopa,
subcutaneous infusion
Antiparkinson Agent
ATC Code: N04BA07
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Qc H4S 1Z1
Date of Initial Authorization:
MAY 03, 2023
Submission Control Number: 263826
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_VYALEV (foslevodopa/foscarbidopa solution) _
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_Page 2 of 53_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
None
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4.4
Administration
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