DYSPORT THERAPEUTIC POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

ABOBOTULINUMTOXINA

Disponibbli minn:

IPSEN BIOPHARMACEUTICALS CANADA INC

Kodiċi ATC:

M03AX01

INN (Isem Internazzjonali):

BOTULINUM TOXIN

Dożaġġ:

300UNIT

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

ABOBOTULINUMTOXINA 300UNIT

Rotta amministrattiva:

INTRAMUSCULAR

Unitajiet fil-pakkett:

1 VIAL

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2017-01-03

Karatteristiċi tal-prodott

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