BOTOX POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ONABOTULINUMTOXINA

Tersedia dari:

ABBVIE CORPORATION

Kode ATC:

M03AX01

INN (Nama Internasional):

BOTULINUM TOXIN

Dosis:

100UNIT

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

ONABOTULINUMTOXINA 100UNIT

Rute administrasi :

INTRAMUSCULAR

Unit dalam paket:

50/100/200 UNITS

Jenis Resep:

Prescription

Area terapi:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0151557001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-09-09

Karakteristik produk

_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.................................................................................................