Țară: Canada
Limbă: engleză
Sursă: Health Canada
PRABOTULINUMTOXINA
EVOLUS INCORPORATED
M03AX01
BOTULINUM TOXIN
100UNIT
POWDER FOR SOLUTION
PRABOTULINUMTOXINA 100UNIT
INTRAMUSCULAR
2.5ML
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0160590001; AHFS:
APPROVED
2018-08-16
_NUCEIVA (prabotulinumtoxinA) _ _ _ _Page 1 of 22 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR NUCEIVA prabotulinumtoxinA for injection Sterile vacuum-dried powder for solution for injection 100 Units per vial Neuromuscular Blocking Agent Evolus, Inc. 520 Newport Center Drive, Suite 1200 Newport Beach, CA 92660 Date of Initial Approval: August 16, 2018 Date of Revision: November 1, 2023 Submission Control No: 274457 _NUCEIVA (prabotulinumtoxinA) _ _ _ _Page 2 of 22 _ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 12/2022 TABLE OF CONTENTS 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 ............................................................................................ 5 4.4 Administration ............................................................................................ 5 5 OVERDOSAGE ...................................................... Citiți documentul complet