Država: Kanada
Jezik: engleski
Izvor: Health Canada
INCOBOTULINUMTOXINA
MERZ PHARMACEUTICALS GMBH
M03AX01
BOTULINUM TOXIN
100UNIT
POWDER FOR SOLUTION
INCOBOTULINUMTOXINA 100UNIT
INTRAGLANDULAR
15G/50G
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0153613001; AHFS:
APPROVED
2009-03-13
_Xeomin_ _®_ _ (incobotulinumtoxinA) - Product Monograph _ _Page 1 of 58_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR XEOMIN ® incobotulinumtoxinA for injection Clostridium Botulinum Neurotoxin Type A (150 kD), free from complexing proteins 50 and 100 units per vial Intramuscular or intraglandular injection Pharmaceutical Standard: House Muscle relaxant, peripherally acting agent Manufactured by: Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/Main Germany http://www.merz.com/company/merz_pharmaceuticals/ Imported and distributed by: Merz Pharma Canada Ltd. 5515 North Service Road, Ste 202 Burlington, ON L7L 6G4 Date of Initial Authorization: March 13, 2009 Date of Revision: October 3, 2023 Submission Control Number: 274814 _Xeomin_ _®_ _ (incobotulinumtoxinA) - Product Monograph _ _Page 2 of 58_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, Chronic Sialorrhea in Pediatric Patients 09/2022 1 INDICATIONS, Spasticity of the Upper Limb 03/2022 1.1 PEDIATRICS, Chronic Sialorrhea in Pediatric Patients 09/2022 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 12/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment, Chronic Sialorrhea in Pediatric Patients 09/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment, Spasticity of the Upper Limb 03/2022 4 DOSAGE AND ADMINISTRATION,4.4, Administration, Chronic Sialorrhea (pediatrics) 09/2022 7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatric Sialorrhea 09/2022 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 ..................................................................... 5 1 INDICATIONS ..................................................................... Pročitajte cijeli dokument