DYSPORT THERAPEUTIC POWDER FOR SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ABOBOTULINUMTOXINA

Disponible desde:

IPSEN BIOPHARMACEUTICALS CANADA INC

Código ATC:

M03AX01

Designación común internacional (DCI):

BOTULINUM TOXIN

Dosis:

500UNIT

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

ABOBOTULINUMTOXINA 500UNIT

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

3ML

tipo de receta:

Prescription

Área terapéutica:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0153614002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2017-01-03

Ficha técnica

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DYSPORT THERAPEUTIC
®
abobotulinumtoxinA
Sterile lyophilized powder for solution for injection
300 and 500 Units per vial
Neuromuscular Blocking Agent
Ipsen Biopharmaceuticals Canada Inc.
5050 Satellite Drive, Suite 500
Mississauga, ON
L4W 0G1
Date of Initial Authorization:
JUN 12, 2012
Date of Revision:
SEP 29, 2023
Submission Control Number: 274955
_ _
_Dysport Therapeutic_
_®_
_ (abobotulinumtoxinA)_
_ _
_ _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
1 Indications
02/2021
4 Dosage & Administration
02/2021
7 Warnings & Precautions
XX/2023
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
...................................................... 4
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................... 5
4.3
Reconstitution
...........................................