País: Canadá
Idioma: inglés
Fuente: Health Canada
PEGVALIASE
BIOMARIN INTERNATIONAL LIMITED
A16AB19
PEGVALIASE
20MG
SOLUTION
PEGVALIASE 20MG
SUBCUTANEOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0163521001; AHFS:
APPROVED
2022-03-30
PALYNZIQ® (pegvaliase injection) Page 1 of 38 _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PALYNZIQ ® pegvaliase injection Solution 2.5 mg/0.5 mL (5 mg/mL), 10 mg/0.5 mL (20 mg/mL), 20 mg/1.0 mL (20 mg/mL) Subcutaneous injection Recombinant phenylalanine ammonia lyase (rAvPAL) is manufactured in _Escherichia coli_ bacteria transformed with a plasmid containing the phenylalanine ammonia lyase (PAL) gene derived from _Anabaena variabilis_ Alimentary Tract and Metabolism Products BioMarin International Limited Shanbally, Ringaskiddy County Cork, Ireland Distributor: BioMarin Pharmaceutical (Canada) Inc. Toronto, ON Canada M5H 3C2 Date of Initial Authorization: MAR 30, 2022 Date of Revision: APR 4, 2023 Submission Control Number: 269980 PALYNZIQ® (pegvaliase injection) Page 2 of 38 _ _ TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 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 A Leer el documento completo