DYSPORT THERAPEUTIC POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ABOBOTULINUMTOXINA

Commercializzato da:

IPSEN BIOPHARMACEUTICALS CANADA INC

Codice ATC:

M03AX01

INN (Nome Internazionale):

BOTULINUM TOXIN

Dosaggio:

300UNIT

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

ABOBOTULINUMTOXINA 300UNIT

Via di somministrazione:

INTRAMUSCULAR

Confezione:

1 VIAL

Tipo di ricetta:

Prescription

Area terapeutica:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0153614001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2017-01-03

Scheda tecnica

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