DYSPORT THERAPEUTIC POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ABOBOTULINUMTOXINA

Dostępny od:

IPSEN BIOPHARMACEUTICALS CANADA INC

Kod ATC:

M03AX01

INN (International Nazwa):

BOTULINUM TOXIN

Dawkowanie:

500UNIT

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

ABOBOTULINUMTOXINA 500UNIT

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

3ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2017-01-03

Charakterystyka produktu

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
...........................................