BOTOX COSMETIC POWDER FOR SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ONABOTULINUMTOXINA

Доступно од:

ABBVIE CORPORATION

АТЦ код:

M03AX01

INN (Међународно име):

BOTULINUM TOXIN

Дозирање:

100UNIT

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

ONABOTULINUMTOXINA 100UNIT

Пут администрације:

INTRAMUSCULAR

Јединице у пакету:

100 UNIT/VIAL

Тип рецептора:

Prescription

Терапеутска област:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2001-04-04

Карактеристике производа

_Botox Cosmetic (onabotulinumtoxinA)_
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BOTOX COSMETIC
®
onabotulinumtoxinA
_Clostridium botulinum_ type A neurotoxin complex (900kD)
Sterile vacuum-dried concentrate powder for solution for injection
50 and 100 Allergan units per vial, intramuscular
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:
APR 04, 2001
Date of Revision:
NOV 04, 2022
Submission Control No: 263461
_ _
_Botox Cosmetic (onabotulinumtoxinA) _
_Page 2 of 27 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Consideration
06/2020
7 WARNINGS AND PRECAUTIONS
06/2020
8 ADVERSE REACTIONS, 8.5 Post Marketing Adverse Reactions
06/2020
9 DRUG INTERACTIONS, 9.4 Drug-Drug Interaction
08/2022
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
..............................................................5
4
DOSAGE AND
ADMINISTRATION..........................................................