Land: Kanada
Språk: engelska
Källa: Health Canada
ONABOTULINUMTOXINA
ABBVIE CORPORATION
M03AX01
BOTULINUM TOXIN
100UNIT
POWDER FOR SOLUTION
ONABOTULINUMTOXINA 100UNIT
INTRAMUSCULAR
50/100/200 UNITS
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0151557001; AHFS:
APPROVED
2022-09-09
_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................................................................................................. Läs hela dokumentet