DYSPORT THERAPEUTIC POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ABOBOTULINUMTOXINA

Mevcut itibaren:

IPSEN BIOPHARMACEUTICALS CANADA INC

ATC kodu:

M03AX01

INN (International Adı):

BOTULINUM TOXIN

Doz:

300UNIT

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

ABOBOTULINUMTOXINA 300UNIT

Uygulama yolu:

INTRAMUSCULAR

Paketteki üniteler:

1 VIAL

Reçete türü:

Prescription

Terapötik alanı:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2017-01-03

Ürün özellikleri

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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
...........................................................................................................
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
...........................................