Riik: Kanada
keel: inglise
Allikas: Health Canada
ABOBOTULINUMTOXINA
IPSEN BIOPHARMACEUTICALS CANADA INC
M03AX01
BOTULINUM TOXIN
300UNIT
POWDER FOR SOLUTION
ABOBOTULINUMTOXINA 300UNIT
INTRAMUSCULAR
1 VIAL
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0153614001; AHFS:
APPROVED
2017-01-03
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DYSPORT THERAPEUTIC ® abobotulinumtoxinA Sterile lyophilized powder for solution for injection 300 and 500 Units per vial Neuromuscular Blocking Agent Ipsen Biopharmaceuticals Canada Inc. 5050 Satellite Drive, Suite 500 Mississauga, ON L4W 0G1 Date of Initial Authorization: JUN 12, 2012 Date of Revision: SEP 29, 2023 Submission Control Number: 274955 _ _ _Dysport Therapeutic_ _®_ _ (abobotulinumtoxinA)_ _ _ _ _ _Page 2 of 36_ RECENT MAJOR LABEL CHANGES 1 Indications 02/2021 4 Dosage & Administration 02/2021 7 Warnings & Precautions XX/2023 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 ...................................................... 4 4 DOSAGE AND ADMINISTRATION .............................................................................. 5 4.1 Dosing Considerations ....................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ................................................... 5 4.3 Reconstitution ........................................... Lugege kogu dokumenti