DYSPORT THERAPEUTIC POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ABOBOTULINUMTOXINA

Dostopno od:

IPSEN BIOPHARMACEUTICALS CANADA INC

Koda artikla:

M03AX01

INN (mednarodno ime):

BOTULINUM TOXIN

Odmerek:

300UNIT

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

ABOBOTULINUMTOXINA 300UNIT

Pot uporabe:

INTRAMUSCULAR

Enote v paketu:

1 VIAL

Tip zastaranja:

Prescription

Terapevtsko območje:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2017-01-03

Lastnosti izdelka

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