DYSPORT THERAPEUTIC POWDER FOR SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ABOBOTULINUMTOXINA

Beschikbaar vanaf:

IPSEN BIOPHARMACEUTICALS CANADA INC

ATC-code:

M03AX01

INN (Algemene Internationale Benaming):

BOTULINUM TOXIN

Dosering:

500UNIT

farmaceutische vorm:

POWDER FOR SOLUTION

Samenstelling:

ABOBOTULINUMTOXINA 500UNIT

Toedieningsweg:

INTRAMUSCULAR

Eenheden in pakket:

3ML

Prescription-type:

Prescription

Therapeutisch gebied:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2017-01-03

Productkenmerken

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