DYSPORT THERAPEUTIC POWDER FOR SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ABOBOTULINUMTOXINA

Saadav alates:

IPSEN BIOPHARMACEUTICALS CANADA INC

ATC kood:

M03AX01

INN (Rahvusvaheline Nimetus):

BOTULINUM TOXIN

Annus:

500UNIT

Ravimvorm:

POWDER FOR SOLUTION

Koostis:

ABOBOTULINUMTOXINA 500UNIT

Manustamisviis:

INTRAMUSCULAR

Ühikuid pakis:

3ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2017-01-03

Toote omadused

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