DYSPORT THERAPEUTIC POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ABOBOTULINUMTOXINA

Pieejams no:

IPSEN BIOPHARMACEUTICALS CANADA INC

ATĶ kods:

M03AX01

SNN (starptautisko nepatentēto nosaukumu):

BOTULINUM TOXIN

Deva:

500UNIT

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

ABOBOTULINUMTOXINA 500UNIT

Ievadīšanas:

INTRAMUSCULAR

Vienības iepakojumā:

3ML

Receptes veids:

Prescription

Ārstniecības joma:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2017-01-03

Produkta apraksts

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