DYSPORT THERAPEUTIC POWDER FOR SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ABOBOTULINUMTOXINA

Dostupné z:

IPSEN BIOPHARMACEUTICALS CANADA INC

ATC kód:

M03AX01

INN (Medzinárodný Name):

BOTULINUM TOXIN

Dávkovanie:

500UNIT

Forma lieku:

POWDER FOR SOLUTION

Zloženie:

ABOBOTULINUMTOXINA 500UNIT

Spôsob podávania:

INTRAMUSCULAR

Počet v balení:

3ML

Typ predpisu:

Prescription

Terapeutické oblasti:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2017-01-03

Súhrn charakteristických

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
......................................................................................
2
TABLE OF CONTENTS
...........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
...........................................................................................................
4
1.2
Geriatrics
...........................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
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
...........................................