BOTOX POWDER FOR SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ONABOTULINUMTOXINA

Fáanlegur frá:

ABBVIE CORPORATION

ATC númer:

M03AX01

INN (Alþjóðlegt nafn):

BOTULINUM TOXIN

Skammtar:

200UNIT

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

ONABOTULINUMTOXINA 200UNIT

Stjórnsýsluleið:

INTRAMUSCULAR

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Vörulýsing:

Active ingredient group (AIG) number: 0151557004; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2022-10-03

Vara einkenni

_Botox (onabotulinumtoxinA) _
_Page 1 of 76 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BOTOX
®
onabotulinumtoxinA
Clostridium botulinum type A neurotoxin complex (900kD)
Sterile vacuum-dried concentrate powder for solution for injection
50, 100 and 200 Allergan units per vial,
intramuscular/intradetrusor/intradermal
Pharmaceutical Standard: Ph. Eur.
Neuromuscular Paralytic Agent (ATC Code: M03AX01)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, QC H4S 1Z1
Date of Initial Approval:
MAR 14, 1990
Date of Revision:
FEB 07, 2024
Submission Control No: 273166
_Botox (onabotulinumtoxinA) _
_Page 2 of 76 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, Focal Spasticity
02/2024
1 INDICATIONS, Pediatric Focal Spasticity
03/2021
1 INDICATIONS, 1.1 Pediatrics
03/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
03/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
02/2024
7 WARNINGS AND PRECAUTIONS, General
03/2021
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3
Pediatrics
03/2021
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..............................................................................................................5
1.2
Geriatrics
..............................................................................................................5
2
CONTRAINDICATIONS.................................................................................................