BOTOX COSMETIC POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ONABOTULINUMTOXINA

Dostopno od:

ABBVIE CORPORATION

Koda artikla:

M03AX01

INN (mednarodno ime):

BOTULINUM TOXIN

Odmerek:

50UNIT

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

ONABOTULINUMTOXINA 50UNIT

Pot uporabe:

INTRAMUSCULAR

Enote v paketu:

100

Tip zastaranja:

Schedule D

Povzetek izdelek:

Active ingredient group (AIG) number: 0151557003; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2022-10-03

Lastnosti izdelka

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